Sean Griffin
- Role
- Vice President of Regulatory Affairs at Galderma
- Location
- Dallas, TX, US
- LinkedIn followers
- 500 followers
About Sean Griffin
Extensive regulatory affairs experience covering all major areas - drugs, biologics…
Experience
Vice President of Regulatory Affairs
Sep 2018 — Present
Responsible for leading Regulatory Affairs activities for North America. Includes strategic input into the development of new products as well as ensuring compliance of marketed prescription drugs, aesthetics/medical devices and over-the-counter drugs, cosmetics and dietary supplement products. Also responsible for leading OTC switch programs including the Rx-to-OTC switch of Differin Gel.
Education
The University of Texas at Arlington
Master of Business Administration (MBA)
2003 — 2005
The University of Texas at Arlington
B.S., Biology
1991 — 1995
Skills
- Regulations
- Regulatory Submissions
- Ind
- Strategy
- Team Building
- Team Leadership
- Dermatology
- Fda
- Good Clinical Practice (Gcp)
- Gmp
- Capa
- Regulatory Requirements
- U.s. Food and Drug Administration (Fda)
- Process Improvement
- Ectd
- Regulatory Affairs
- Drug Development
- U.s. Title 21 Cfr Part 11 Regulation
- Dietary Supplements
- Medical Writing
- Pharmacovigilance
- Technology Transfer
- Nda
- CRO
- Otc-Switch
- Medical Devices
- Ich-Gcp
- Clinical Trials
- Gcp
- Clinical Development
- Clinical Research
- Iso 13485
- Strategic Leadership
- Ctms
- Change Control
- Consulting
- Sop
- Staff Management
- Cmc
- Ophthalmology
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