Director, Regulatory Affairs CMC
Generate BiomedicinesSomerville, Massachusetts, United States • Massachusetts, United States
Posted March 11, 2026
186000 - 279000 USD
Full Time
About the Company
Generate:Biomedicines is a therapeutics company pioneering Generative BiologyTM to create breakthrough medicines using machine learning, biological engineering, and medicine.
Job Description
Generate:Biomedicines is seeking an experienced Director, Regulatory Affairs to lead global regulatory strategy and execution across CMC and clinical development programs. The ideal candidate brings a deep understanding of global CMC regulatory requirements and hands-on experience leading Health Authority interactions.
Requirements
- 10+ years of Regulatory Affairs experience in biotechnology or pharmaceutical industries
- Significant expertise in Regulatory CMC and a solid understanding of clinical and nonclinical development
- Proven experience supporting Phase 3 global development programs and registration submissions
- Deep understanding of biologics manufacturing, analytical development, and quality systems within a regulatory framework
- Strong knowledge of global regulatory requirements (FDA, EMA, MHRA, PMDA, and ICH)
- Familiarity with eCTD submission standards and regulatory information management systems (e.g., Veeva)
- Excellent communication and leadership skills
Benefits
- Annual bonus
- Equity compensation
- Competitive benefits package
