Vice President of Regulatory Affairs
New
Europe, USAFull-TimeVp
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum 15 years
- Required Skills
- Budget management
Requirements
- Advanced degree in Pharmacy, Medicine, Biology, Chemistry, or related fields.
- Minimum 15 years experience in regulatory affairs.
- At least 10 years experience directly engaging with FDA/EMA.
- Proven senior leadership experience in multinational pharma/biotech.
- Successful IND/NDA/BLA or MAA approvals.
- In-depth knowledge of regulatory pathways for metabolic diseases.
- Familiarity with regulatory requirements across all phases of clinical development.
- Demonstrated success in complex, matrixed organizations.
- Fluency in English (written and spoken).
Responsibilities
- Develop and execute regulatory strategies for the U.S. and EU markets.
- Lead interactions with FDA, EMA, and other authorities.
- Represent the company in regulatory meetings, hearings, and negotiations.
- Lead and develop the regional regulatory affairs team.
- Oversee regulatory affairs budgets.
- Implement and optimize regulatory processes and knowledge databases.
- Monitor regulatory policy changes.
- Collaborate closely with R&D, clinical, commercial, pharmacovigilance, and quality teams.
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