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Lead Manager of Regulatory Compliance
2 months ago
At Immatics NV, we are dedicated to innovation and excellence in the field of cellular therapies.
Position Overview:
The Senior Manager of CMC Regulatory Affairs plays a pivotal role in shaping the regulatory strategies for our cellular product candidates. This position requires close collaboration with various teams, including Process Development, Manufacturing, and Quality Assurance. A key responsibility is the authorship and upkeep of CMC documentation for regulatory submissions. The ideal candidate will possess a robust understanding of global regulatory CMC requirements and will be adept at providing regulatory guidance to cross-functional project teams.
Key Responsibilities:
- Develop and refine regulatory CMC strategies for cellular product candidates, particularly in relation to manufacturing process modifications and validation.
- Draft and maintain CMC documentation for INDs and EU CTAs, working alongside international project teams.
- Prepare responses to CMC inquiries from regulatory authorities, including the FDA and EU Competent Authorities.
- Assist in the preparation of meeting requests and materials for Health Authority discussions from a regulatory CMC perspective.
- Evaluate and process change control procedures within the manufacturing domain.
- Conduct research and analysis on regulatory requirements, ensuring effective communication across functions.
- Contribute to the development and review of Standard Operating Procedures (SOPs) and policies pertinent to CMC Regulatory Affairs.
- A degree in a scientific discipline (e.g., biology, chemistry, or pharmacy) or a master's degree in Regulatory Affairs is preferred.
- A minimum of four years of experience in Regulatory Affairs CMC, specifically for gene and cellular therapies.
- Proven ability to coordinate tasks and navigate a highly regulated environment with international stakeholders.
- Strong organizational and time management skills.
- Proactive issue management and conflict resolution abilities.
- Excellent verbal and written communication skills.
- In-depth knowledge of global regulations and GMP guidelines.
This role is primarily sedentary, requiring the ability to engage in typical office activities. The environment may include moderate noise levels and frequent use of office equipment.
Travel Requirements:
- Occasional domestic and international travel may be necessary.
Eligibility to work in the United States is mandatory. Immatics NV participates in E-Verify and complies with all employment eligibility verification requirements.
