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Contract Senior Manager, Regulatory Affairs
Key Responsibilities
- Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities
- Serve as the regulatory affairs subject matter expert on cross-functional study and submission teams
- Correspond and collaborate with internal colleagues across functions to ensure alignment on regulatory strategy and deliverables
- Conduct regulatory research and intelligence activities to inform business strategy and assess risk
- Identify and communicate potential regulatory compliance risks and recommend solutions
- Establish and maintain effective working relationships with Clinical, Clinical Operations, and CRO counterparts to support cross-functional alignment
- Contribute to the development of regulatory strategies, including associated budgets and operational support requirements
Qualifications
- Bachelor’s degree in a relevant field or equivalent experience
- Minimum of 5 years of direct regulatory affairs experience in the pharmaceutical or biotechnology industry
- Strong working knowledge of US FDA pharmaceutical regulations and guidance
- Proven track record of successful submissions within a regulatory environment, including IND and/or Clinical Trial Application filings
- Global clinical trials experience required
- Knowledge of EU EMA regulations and clinical trial requirements a plus
- Excellent communication, planning, and organizational skills