Director of Pharmaceutical Compliance
4 days ago
Cpl Healthcare collaborates with a reputable global consultancy firm.
The company specializes in supporting pharma, biotech, spin-out, and academic groups with drug development activities.
This includes advanced therapies, cell therapy, ATMPS, and other niche therapeutic areas.
Role Overview:
The Senior Director of Regulatory Affairs will lead client projects, providing strategic regulatory advice.
- Gap analyses, filing routes, regulatory interactions, and designations.
- Prepare regulatory submission documents, including orphan drug designation applications.
- Clinical trial applications and marketing authorisation applications.
Main Responsibilities:
- Lead regulatory agency interactions/negotiations.
- Manage complex regulatory projects, mitigating risks.
- Provide leadership to a team of 4 regulatory affairs professionals.
- Support development plans, offer training, and mentor regulatory staff.
- Contribute to regulatory intelligence, maintaining up-to-date knowledge.
Qualifications:
- At least 12+ years in Regulatory Affairs within a complex therapeutic area.
- Experience with EMA (scientific advice, orphan designation, PIPs).
- Experienced in driving global Regulatory Affairs Strategies.
- Willingness to work hybrid, with an office presence (2/3 days on-site per week).
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