Senior CMC Regulatory Affairs Manager
vor 3 Wochen
Position Overview
Gilead Sciences Switzerland Sarl is seeking a seasoned professional to join our CMC Regulatory Affairs team as a Senior Manager. This role will focus on managing CMC regulatory responsibilities for designated regions.
Role Summary
The Senior Manager of CMC Regulatory Affairs is integral to the Global CMC RA organization, acting as the primary CMC RA representative for specific products and regions. You will work closely with international teams to formulate and implement CMC regulatory strategies that support the objectives of Product Development Management.
Key Responsibilities
- Draft and review CMC sections for a variety of regulatory submissions throughout the product lifecycle.
- Ensure compliance of regulatory submissions with ICH and regional standards.
- Manage CMC regulatory submissions, including those for clinical trials, marketing approvals, and post-approval modifications.
- Engage with regulatory authorities to resolve CMC inquiries and ensure prompt communication.
- Provide expertise in CMC regulatory requirements to contribute to the global filing strategy.
Essential Skills and Competencies
- Ability to develop and execute regulatory strategies effectively.
- Coordinate the preparation of comprehensive CMC regulatory documentation.
- Implement risk-based methodologies in regulatory processes.
- Demonstrate strong organizational and communication abilities.
- Exhibit effective negotiation and influence skills.
- Possess critical and strategic thinking capabilities.
Qualifications and Experience
- A minimum of 8 years of experience in CMC regulatory activities for small molecules.
- Proficiency in English and German.
- Solid understanding of ICH and EU CMC regulatory frameworks.
- Experience in compiling and submitting regulatory documents.
- Familiarity with interactions with health authorities.
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