Global Regulatory Lead Pharmaceutical Candidates Sample Search Report

100%

V P

Collegeville, Pennsylvania, United States 26 years 10 months

This candidate is an excellent match, holding extensive global regulatory strategy and submission experience across all major development phases within pharma. Accomplished global Regulatory Affairs strategist → Global regulatory CMC leader, focused on INDs, CTAs, NDA/MAA/BLAs. Excellent.

LinkedIn Email Phone

Work Experience

Dr. Reddy's Laboratories

Scientist - Group Lead (Anti-Diabetic Research & Development) · 1 year 5 months

Pfizer

Regulatory Affairs Manager · 6 months

Onconova Therapeutics

Consultant - CMC & Regulatory Affairs · 7 years 8 months

Palatin Technologies /Thomas Jefferson University

Research Associate - (Pre-Clinical Development) · 3 years 1 month

+ 5 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

strategy clinical marketing management ind container health reports preparation briefing assurance compliance +8 more

100%

R** H*

Director, Regulatory Affairs | Global Regulatory Strategy (U.S., Canada, EU, AU) | IND-CTA-BLA Expertise | U.S.-Based Remote Leader

La Vergne, Tennessee, United States 17 years 4 months

The profile explicitly describes functioning as a global regulatory strategy director deeply involved in drug development submissions (IND, BLA). Director, RA focusing on Global Strategy U.S./Canada/EU/AU → multi-director roles across 17+ years. Excellent.

LinkedIn Email Phone

Work Experience

ICON Clinical Research

Senior Regulatory Document Specialist · 5 months

Therapeutic Antibodies, Inc.

Regulatory Affairs Associate · 3 years 7 months

Protherics, Inc.

Associate Director of Regulatory Affairs · 1 year 9 months

Novotech

Director Regulatory Affairs · 1 year 2 months

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

strategy ind health performing driving sop compliance efficiency marketing mentoring collaboration clinical +8 more

100%

R H

Vice President Global Drug Regulatory Affairs at Fresenius Medical Care

Saugus, Massachusetts, United States 25 years 11 months

Excellent match; this person is a current VP of Global Regulatory Affairs with extensive experience driving submissions (INDs, NDAs, MAAs) at large pharma companies. VP Global Regulatory Affairs @ Fresenius → Sr Dir @ Alkermes → VP Global Regulatory Affairs @ Fresenius, CNS focus, FDA negotiation expert. Excellent.

LinkedIn Email Phone

Work Experience

Fresenius Medical Care North America

Vice President Global Regulatory Affairs

ARIAD Pharmaceuticals, Inc.

Director, Regulatory Affairs · 2 years

Fresenius Medical Care North America

Senior Director Regulatory Affairs · 7 years 10 months

Alkermes

Senior Director, Regulatory Affairs | Regulatory Affairs Strategy | Regulatory Affairs Management · 8 years

+ 1 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

director rfp publishing strategy assessment ind negotiations liaison hiring budget intelligence sop +8 more

100%

S** S*

Regulatory Affairs Strategy | Neuroscience & Oncology (Drugs, Biologics, Gene Therapy) | Regulatory Project Management | Regulatory Operations | Quality Assurance

Boston, Massachusetts, United States 13 years 1 month

Perfect match; current Global Program Regulatory Manager leading strategy and submissions (IND, CTA) for neuroscience projects at Novartis. Global Program Regulatory Manager @ Novartis (Neuroscience/Gene Therapy), strong global submission history. Excellent.

LinkedIn Email Phone

Work Experience

Marck Biosciences Ltd.

Production Chemist · 1 year 11 months

Leal Therapeutics

Sr Manager, Regulatory Affairs & QA · 1 year 1 month

Leal Therapeutics

Associate Director, Regulatory Affairs & QA · 3 months

Cadent Therapeutics (Acquired by Novartis Pharmaceutical)

Senior Associate, Regulatory Affairs & Quality Assurance · 1 year 9 months

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

planning strategy compliance driving health pharmaceuticals neuroscience projects ind safety reports liaison +8 more

100%

M Q

Director, Global Regulatory Lead - Oncology, at Johnson & Johnson

Milltown, New Jersey, United States 39 years

This is an excellent fit, with the candidate currently holding the title 'Director, Global Regulatory Lead' and possessing extensive experience in both global strategy and drug development regulatory within the Pharmaceutical industry. J&J → Merck, 39 years total experience. Excellent.

LinkedIn Email Phone

Work Experience

Merck & Co, Inc

Director, Global Regulatory Affairs

Johnson & Johnson

Director, Global Regulatory Lead - Oncology

Merck & Co, Inc

Manager, Global Regulatory Affairs · 8 years

Merck & Co, Inc

Director/Associate Director, Global Regulatory Affairs · 8 years

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

product life cycle management planning clinical management mentoring leadership coaching director oncology strategy manufacturing documentation +8 more

100%

C R

Director at Merck

Los Angeles, California, United States 19 years 5 months

This candidate explicitly lists all required fields in their skills and has a long history managing global regulatory programs in the pharmaceutical industry supporting drug development strategy. Merck experience (19+ years), explicitly lists all required skills/focus areas. Excellent.

LinkedIn Email Phone

Work Experience

Merck

Associate Director · 15 years

Merck

Director · 4 years 5 months

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

director regulatory affairs pharmaceutical industry drug development

100%

M M

Senior Vice President, Regulatory Affairs and Quality

Waltham, Massachusetts, United States 33 years 1 month

An excellent match, this candidate has extensive SVP level experience leading global regulatory affairs teams supporting new product development across multiple health authorities. Pharma industry (25+ years) in leadership roles (SVP). Excellent.

LinkedIn Email Phone

Work Experience

Upstream Bio

Program Lead

University of Delaware

Faculty- Clinical Trial Management Certification program

Nabriva Therapeutics plc

Vice President, Regulatory Affairs

Teva Pharmaceuticals

Global Regulatory Affairs Lead -CNS / Director Regulatory Affairs

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

leadership management accountability deployment neuroscience psychiatry gastroenterology liaison health committees ectd coaching +8 more

100%

Y** X

Director Global Regulatory Affairs

New York City Metropolitan Area, United States 9 years 7 months

An excellent match, currently serving as Director/Senior Director leading global regulatory strategy and submissions for oncology products in major pharma companies. Bayer → AstraZeneca → Eli Lilly (Sr Dir Global RA Lead). Strong.

LinkedIn Email Phone

Work Experience

Bayer

Global Regulatory Affairs Intern

Eli Lilly and Company

Senior Director Global Regulatory Lead

Bayer Pharmaceuticals

Associate Director Global Regulatory Affairs Strategy

AstraZeneca

Director Global Regulatory Affairs AstraZeneca

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

director strategy ind supplements oncology research assessment preparation cancer hematology regulatory affairs due diligence

100%

A* S**

Senior Director, Strategy and agency Liaison-Global Regulatory Affairs at ICON plc

United States 31 years 5 months

This individual has a long tenure leading global regulatory strategy, including INDs, NDAs, and BLAs, which perfectly matches the job requirements. Exec Dir, RA at Travere → Sr Dir, Strategy/Liaison at ICON, previously Sr Dir Strategy/Ops at Armata developing strategies for filings. Excellent.

LinkedIn Email Phone

Work Experience

Baxter Healthcare Corporation

QA Product Release Specialist · 2 years 8 months

Baxter HEALTHCARE CORP

RA AssociateIII · 2 years 1 month

Baxter HEALTHCARE CORP

Regulatory Affairs Manager/Senior Manager · 5 years 9 months

Baxter HEALTHCARE CORP

RA AssociateII · 2 years 8 months

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

regulatory affairs market entry knowledge sharing quality assurance quality control cell culture regulatory requirements development management raw materials regulatory submissions design control clinical research +8 more

100%

A* S**

Regulatory Leader Advancing Drug Development and Global Teams

San Francisco, California, United States 25 years 3 months

Excellent fit—this candidate is explicitly a Global Regulatory Pharmaceutical Leader with broad development and global agency experience including NDAs/BLAs/MAAs and WHO listing.

LinkedIn Email Phone

Work Experience

Catalyst Regulatory Services

Associate Director · 2 years

Shionogi Pharma (formerly Sciele Pharma)

Senior Manager, Regulatory Affairs · 1 year 7 months

Moderna

Senior Director, Global Regulatory Science - Oncology · 3 years 4 months

Moderna

Executive Director, Global Regulatory Science

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

strategy clinical research oncology immunology biologics antibodies marketing management fluent recruiting hiring +8 more

100%

A G

Vice President, Global Regulatory Affairs

Flanders, New Jersey, United States 28 years 5 months

This candidate is an excellent fit, currently serving as VP of Global Regulatory Affairs with extensive experience across drug development stages in the pharma industry. PhD Chem → MS RA/QA, 15+ years experience. Amarin Corp (VP Global RA). General Electric (early career). Excellent.

LinkedIn Email Phone

Work Experience

ARG Consulting LLC

Regulatory CMC and Quality specialist · 6 years

ARG Consulting LLC

Regulatory and Quality Consultant · 1 year

Schering-Plough

Analytical Specialist · 6 years 3 months

Regado Biosciences

Manager, Regulatory Affairs and Quality Assurance · 3 years 1 month

+ 3 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

training assurance regulations biologics clinical ind preparation spa responsible marketing manufacturing cvs +8 more

100%

M K

Executive Director - Regulatory Affairs

Montville, New Jersey, United States 22 years 7 months

An excellent fit with Executive Director level experience across US and Global Regulatory Affairs, heavily focused on CMC, spanning the entire drug development lifecycle at a major pharmaceutical company. Career: Bayer (Lab Ops Mgr → Assoc Dir CMC → Sr Director → Exec Director Global/US RA). Excellent.

LinkedIn Email Phone

Work Experience

Bayer

Executive Director - Regulatory Affairs Cross Project Network

Berlex Laboratories

Manager, Laboratory Operations · 2 years 1 month

Bayer

Senior Director - Group Head, Regulatory Affairs Established Products · 3 years 1 month

Berlex Laboratories

Manager, Quality Control · 2 years 2 months

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

regulatory affairs issue management product development quality control raw materials business management project management director responsible outsourcing management laboratory +6 more

100%

R P

Chief Regulatory & Quality Officer at Vor Biopharma

United States 51 years 11 months

This executive has extensive experience leading global regulatory strategy across major pharmaceutical and biotech firms. Chief Regulatory/Quality Officer roles at Vor Bio, DBV, Voyager, ViroPharma, Millennium, SmithKline Beecham → C-level biotech/Pharma leadership. Excellent.

LinkedIn Email Phone

Work Experience

The Ohio State University

Instructor in Clinical Pharmacy and Clinical Pharmacy Specialist

SmithKline Beecham

Vice President and Director, Anti-Infective and Anti-Viral Therapeutic Areas

Vor Bio

Chief Regulatory Officer

DBV Technologies

Chief Regulatory Officer

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

clinical pharmacy director strategy hospitals pharmacology assurance management pharmaceuticals treatment prevention clinical pharmacy +6 more

100%

C G

Director, Global Regulatory Strategy

Buffalo Grove, Illinois, United States 23 years 5 months

This candidate clearly has extensive experience leading global regulatory strategy within major pharmaceutical companies. AbbVie → Lundbeck → Takeda Pharma, 20+ years, strong global strategy focus. Excellent.

LinkedIn Email Phone

Work Experience

Lundbeck

Director, Regulatory Strategy · 1 year 8 months

AbbVie

Director, Global Regulatory Strategy, AbbVie

Takeda Pharmaceuticals

Regulatory Strategy Product Manager · 1 year 7 months

Abbott Laboratories

Associate Scientist, Cellular and Molecular Toxicology · 5 years

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

therapeutic areas regulatory affairs strategy diagnostics management leadership director toxicology

100%

E S

Senior Director, Regulatory Affairs at LEO Pharma

Florham Park, New Jersey, United States 25 years 9 months

This professional has deep experience leading global regulatory strategy within pharmaceutical organizations across the drug development lifecycle. Senior Director, RA Strategy at Sarepta → Senior Director, RA at LEO Pharma, focused on dermatology/neuro/cardio/pulmonary. Excellent.

LinkedIn Email Phone

Work Experience

Hoffmann-Roche Inc.

Post-doctoral Fellow · 2 years 1 month

Sarepta Therapeutics, Inc.

Senior Director, Regulaty Affairs Strategy

LEO Pharma

Senior Director, Regulatory Affairs Strategy · 3 years

Hoffman-La Roche Inc.

Program Director, Associate Director, Sr. Program Manager, Program Manager · 11 years 3 months

+ 2 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

dermatology neurology marketing driving conflict spanish director strategy clinical commercial preparation management +8 more

100%

C S

Vice President, Medicine Development Leader at GSK

Lewes, Delaware, United States 23 years 8 months

This candidate has recent, high-level global regulatory experience directly in the pharmaceutical industry, leading development efforts. GSK → AstraZeneca → Intervet/Schering-Plough Animal Health (Head of US Regulatory Affairs), current VP role implies leadership. Excellent.

LinkedIn Email Phone

Work Experience

GSK

Sr. Director, Global Regulatory Lead, Pharma · 2 years 5 months

AstraZeneca

Regulatory Affairs Manager · 10 months

AstraZeneca

Associate Director, Group Manager Regulatory Affairs · 1 year

Intervet Inc

Global Project Leader · 1 year 4 months

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

director clinical research vaccines therapeutic areas regulatory affairs clinical research

100%

N A

Montclair, New Jersey, United States 25 years 4 months

This Director level candidate is an excellent fit, currently implementing global regulatory strategies from IND through NDA approval in pharma, including oncology focus. Pfizer (Dir Global Reg Sci) → other roles. Master's RA, RAC certified. Excellent.

LinkedIn Email Phone

Work Experience

Wyeth Consumer Healthcare

Senior Manager, Global Regulatory Affairs (Dietary Supplements / OTC Drugs) · 2 years 4 months

Pfizer

Director, Global Regulatory Sciences - Oncology · 5 years

Pfizer Consumer Healthcre

Senior Manager, Worldwide Regulatory Strategy (OTC Drugs) · 7 years 2 months

Herbalife International of America

Manager, Regulatory Affairs · 7 years

+ 2 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

oncology ind marketing science director responsible collaboration prescription health negotiations management risk +8 more

100%

T* P**

Vice President, Global Regulatory Affairs

Whippany, New Jersey, United States 26 years 9 months

This individual is currently or very recently at the VP/Global Head level for Regulatory Affairs in major pharma companies, perfectly matching the job scope. Roche → Bayer → Sanofi (VP, Global Head of Regulatory Affairs, Specialty Care). Excellent.

LinkedIn Email Phone

Work Experience

Merck

Regulatory Leader, Global Regulatory Affairs · 2 months

Sanofi

Vice President, Global Head of Regulatory Affairs, Specialty Care

Bayer

Vice President, Global Regulatory Affairs; R&D Site Head · 8 years 9 months

Roche Pharmaceuticals

Global Franchise Head; Regulatory Site Head; PD Site Leader · 3 years 3 months

+ 2 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

regulatory affairs r director

100%

V A

Director, Regulatory Strategy

Boston, Massachusetts, United States 24 years 8 months

Excellent fit, currently holds a senior role as Global Regulatory Lead for Oncology at Moderna. Global Regulatory Lead - Oncology @ Moderna → Assoc Dir @ Merck → Dir Regulatory Strategy @ Moderna, extensive global filing experience. Excellent.

LinkedIn Email Phone

Work Experience

Merck

Associate Director, Global Regulatory Affairs - Oncology · 2 years 8 months

Moderna

Global Regulatory Lead- Oncology

Moderna

Director, Regulatory Strategy LATAM

AstraZeneca

Regulatory Affairs & Quality Assurance Manager- Colombia · 7 years 1 month

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

oncology director liaison strategy assurance compliance health management gxp distribution inspection marketing +8 more

100%

W S

Principal Consultant at Self Employed

St. Cloud, Florida, United States 43 years 9 months

This candidate possesses extensive experience across global regulatory affairs in the pharmaceutical sector, perfectly aligning with a lead role. Career: FDA reviewer → PharmaR&D Services → AbbVie → Self Employed Consultant, 35+ years regulatory/QA/clinical dev. Excellent.

LinkedIn Email Phone

Work Experience

AbbVie

Director, US Regulatory Affairs · 2 years

Takeda Pharmaceuticals

Director · 2 years

Trius Therapeutics

Sr Vice President · 1 year 3 months

PharmaR&D Services

Principal · 5 years 1 month

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

assurance clinical responsible planning director commercialization pharmacology compliance pharmacokinetics government legal less +8 more

100%

M* C**

President at MEC Regulatory & Toxicology Consulting, LLC

Moorpark, California, United States 37 years 3 months

This consultant has extensive experience across regulatory strategy, especially in senior leadership roles within major pharma. Ex-Wyeth → Amgen (Exec. Dir) → 10+ years consulting (RAC certified). Excellent.

LinkedIn Email Phone

Work Experience

NDA Partners LLC

Consultant · 10 years 10 months

Amgen

Senior Director Toxicology · 10 years 1 month

Wyeth

Study Director, Manager of Regulatory Toxicology, Bioresearch Monitoring specialist · 8 years 11 months

USC School of Pharmacy

Adjunct Professor · 8 years 11 months

+ 5 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

regulatory affairs quality assurance emerging markets director toxicology assurance safety

100%

C L

Exec. Director Regulatory Affairs CMC at Bayer Pharmaceuticals

Whippany, New Jersey, United States 25 years 8 months

This candidate has Executive Director level experience with clear global responsibility covering drug development regulatory milestones within a major pharmaceutical company. Career: Research Scientist DuPont → Bayer (multiple RA CMC roles incl Director/Exec Director). Excellent.

LinkedIn Email Phone

Work Experience

Bayer Pharmaceuticals

Dept. Director Global Regulatory Affairs CMC · 8 years 9 months

Bayer Pharmaceuticals

Exec. Director Regulatory Affairs CMC · 4 years 9 months

Bayer Pharmaceuticals

Laboratory Operations Manager · 5 years 10 months

Bayer Healthcare Pharmaceuticals

CMC Project Coordinator · 4 years 7 months

+ 1 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

projects ind maintenance director laboratory operations research therapeutic areas regulatory affairs

100%

L M

Board Of Directors, Biotechnology Companies, Neurological Diseases

Washington, District of Columbia, United States 40 years 3 months

Excellent fit—this candidate has recent roles as VP and Global Head of Regulatory Affairs, leveraging extensive global regulatory strategy experience in biotech and pharma. Schering-Plough → Pharmacia → Novartis (VP/Exec Dir Global RA) → REGENXBIO (VP RA) → Consulting/Board. Excellent.

LinkedIn Email Phone

Work Experience

Schering-Plough Research Institute

Manager International Regulatory Affairs · 2 years

Pharmacia

Global regulatory affairs, Oncology · 1 year

Forest Laboratories

Associate Director · 1 year

Hoechst

Manager Health Risk Assessment · 7 years

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

commercialization energy consulting innovation oncology director health risk assessment government safety environmental +8 more

100%

H R

Senior Vice President of Regulatory Affairs at Centessa Pharmaceuticals

Phoenixville, Pennsylvania, United States 29 years 5 months

Excellent fit - serving as SVP/Head of Global Regulatory Affairs with extensive experience leading worldwide developmental projects across major pharma products. 20+ years pharma industry exp (Hend-end pharma) → SVP, Head of Global RA at Madrigal/Centessa. Excellent.

LinkedIn Email Phone

Work Experience

Hahnemann University Hospital

Postdoctoral Fellow · 2 years 2 months

Centessa Pharmaceuticals

Senior Vice President, Regulatory Affairs

Shire

Manager / Senior Manager / Associate Director, Regulatory Affairs · 3 years 2 months

Wyeth Pharmaceuticals

Senior Scientific Writer / Senior Clinical Writer II · 3 years

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

research training maintenance advertising writing strategy projects neuroscience campaigns health pharmaceuticals director +5 more

100%

B S

Principal Regulatory Strategist

United States 25 years

Excellent fit having served in roles like Executive Director, Global Regulatory Affairs and Principal Regulatory Strategist, driving global strategy for biologics and small molecules. Ex-Pharvaris (Global regulatory affairs lead) → Quantum Regulatory → Immunovant (Head of Regulatory Affairs, global leadership/strategy). Excellent.

LinkedIn Email Phone

Work Experience

Abbott Laboratories

Associate Director, Global Regulatory Affairs · 1 year 11 months

Abbott Laboratories

Manager, EU Regulatory Affairs · 1 year 4 months

Takeda

Senior Director, Global Regulatory Affairs Development · 2 years

Akebia Therapeutics

Head of Regulatory Affairs · 9 months

+ 6 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

drug development therapeutic areas people development regulatory affairs project management strategy execution monoclonal antibodies medical writing executive leadership strategy licensing evaluation +8 more

100%

T* F**

Senior Vice President for Regulatory Affairs at Anavex Life sciences Corp

Gaithersburg, Maryland, United States 32 years 1 month

This senior executive has spent significant time in both regulatory consulting and holding senior regulatory roles, coordinating submissions globally, which strongly aligns with the Global Regulatory Lead requirement within the pharmaceutical context. Anavex Life Science Corp → FDA → Freelance Consulting. Excellent.

LinkedIn Email Phone

Work Experience

FDA

Intramural Research Program Director · 9 years 1 month

Freelance

Drug Development Regulatory Consultant

TF Regulatory Consult

President & CEO

FDA

Clinical Phamacology Reveiwer/Team Leader · 14 years 8 months

+ 1 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

science clinical design research director regulatory affairs regulatory submissions drug development

100%

A** I

Daiichi Sankyo Inc - Global Regulatory Lead

United States 11 years 6 months

This candidate is an excellent fit, currently working as a Global Regulatory Lead in pharma and holding significant global regulatory strategy experience. Daiichi Sankyo Inc → Global Regulatory Lead – Oncology | Assoc Dir, Global Regulatory Strategy @ Daiichi Sankyo → Regulatory Affairs @ GSK. Excellent.

LinkedIn Email Phone

Work Experience

Daiichi Sankyo Inc

Global Regulatory Lead · 1 year 8 months

Daiichi Sankyo

Global Regulatory Lead – Oncology | Associate Director, Global Regulatory Strategy

GSK

Regulatory Affais · 6 years

Daiichi Sankyo

Regulatory Affais · 4 years

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

oncology director strategy

100%

M** R*

Executive Vice President, Head of Regulatory Affairs and Quality Assurance, NeuroTrauma Sciences

Scotch Plains, New Jersey, United States 28 years 4 months

This individual has held SVP/EVP roles covering Global Regulatory Affairs Strategy and Commercial affairs for nearly three decades across major pharmaceutical companies like Pfizer and Eisai, making them an excellent fit. Merck → Pfizer → Eisai → Kira → NeuroTrauma Sciences. Excellent.

LinkedIn Email Phone

Work Experience

Pfizer, Inc.

Director, WW Regulatory Strategy · 6 years 11 months

Eisai US

Executive Director, Global Regulatory Affairs, Head of Neuroscience · 1 year 7 months

Eisai US

Senior Director, Global Regulatory Affairs, Head of Neuroscience · 2 years 8 months

Kira Pharmaceuticals

Senior Vice President · 1 year 6 months

+ 4 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

assurance director strategy neuroscience commercial neurology regulatory affairs quality assurance

100%

E* P**

Director, Regulatory Affairs International at Merck

United States 28 years 5 months

This candidate has a strong track record as a Director of International Regulatory Affairs in the pharmaceutical sector, with early career CMC development experience. Director, Regulatory Affairs International at Merck → CMC Pharmaceutical Research and Development at Forest Laboratories. Excellent.

LinkedIn Email Phone

Work Experience

Forest Laboratories

Scientist III to V, CMC Pharmaceutical Research and Development · 9 years 9 months

Merck

Director, Regulatory Affairs International

Merck

Associate Director, Regulatory Affairs International · 1 year 7 months

Merck

Manager, Regulatory Affairs International · 3 years 3 months

+ 2 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

regulatory affairs pharmaceutical research director research

100%

M V

Director, Regulatory Affairs at Organogenesis, Inc

San Diego County, California, United States 37 years 10 months

This candidate has extensive leadership experience in global regulatory affairs within the pharmaceutical and biotech space. Director, Regulatory Affairs at Organogenesis → Director - Regulatory Affairs CMC at Shire Regenerative Medicine → Assoc. Director, US Regulatory Affairs - Vaccines at GlaxoSmithKline Biologicals. Excellent.

LinkedIn Email Phone

Work Experience

AVENTIS BEHRING (Marburg, GERMANY)

Director, Regulatory Affairs, Establishment Group · 3 years

Cambridge Biotech

Regulatroy Affairs · 4 years

CENTEON, LLC (became Aventis Behring)

Associate Director, Drug Regulatory Affairs · 3 years

AVENTIS BEHRING

Director, Worldwide Compliance · 3 years

+ 5 more positions

Qualification Criteria 4 met

Pharmaceutical industry

Regulatory Affairs Lead

Drug development regulatory

Global Regulatory experience

Skills & Expertise

biologics director liaison supplements testing gmp compliance german less reports responsible manufacturing +8 more

Candidate Profiles

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Qualification Criteria 4 met

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Qualification Criteria 4 met

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Qualification Criteria 4 met

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Qualification Criteria 4 met

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Work Experience

Qualification Criteria 4 met

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Qualification Criteria 4 met

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