What are the responsibilities and job description for the Senior Director, Regulatory Affairs CMC position at Proclinical Staffing?
Senior Director, Regulatory Affairs CMC – Permanent – Massachusetts
Proclinical is seeking a Senior Director, Regulatory Affairs CMC for a growing global oncology-focused biotechnology company based in the Greater Boston, MA Area.
Primary Responsibilities:
In this role, you will be responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for product candidates, from the transition from Research to Development through to product licensure. The role will be responsible for the oversight and leading the development and implementation of CMC regulatory strategies, ensuring timely and compliant regulatory submissions, and managing the coordination of internal and external CMC regulatory activities, including those related to co-development partnerships. This role requires significant expertise in regulatory affairs for biologics and/or biopharmaceuticals, with a deep understanding of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP.
The position is based in Cambridge, MA in a hybrid work schedule.
Skills & Requirements:
- MSc or PhD in Life Sciences, Bioengineering, or a related field.
- At least 12 years of relevant working experience within the (bio)pharmaceutical industry or in other relevant regulatory functions, with strong expertise in CMC regulatory affairs.
- Proven experience in CMC regulatory submissions (IND/IMP/MAA/BLA) for both biologic products and small molecules.
- In-depth knowledge of Regulatory Affairs in the EU and US markets, with a strong understanding of relevant regulatory frameworks.
- Ability to think strategically and contribute to the development of CMC regulatory strategies.
The Senior Director, Regulatory Affairs CMC will:
- Preparation, Review, and Approval of CMC Regulatory Filings: Lead the preparation and regulatory submission of CMC sections for regulatory filings (e.g., IMPD/IND/MAA/BLA). Ensure all submissions are accurate, compliant, and submitted in a timely manner.
- Oversee CMC Regulatory Affairs Strategy: Jointly develop and implement CMC regulatory strategies for product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
- Management and Coordination of CMC Regulatory Activities: Oversee and coordinate all internal and external CMC regulatory activities related to product candidates, including activities with external partners and contractors, and those in co-development or partnership.
- Defining CMC Regulatory Affairs Strategy: Jointly develop the CMC regulatory strategies for product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( 1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
