Our client is a growing immuno-oncology company focused on the discovery and development of the next generation of combination treatments in immuno-oncology. The Regulatory CMC Director will join a motivated and newly formed Regulatory Science & Pharmacovigilance business unit aimed at bringing regulatory innovation in drug development and commercialization. This new position is responsible for overseeing the development and implementation of global regulatory CMC strategies for product development and commercialization. You will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submission applications and health authority interactions.
Responsibilities
- Design, develop, and implement regulatory CMC strategy for a portfolio of biologic programs
- Deliver regulatory strategy objectives for global regulatory CMC, including operational risk management
- Work collaboratively across functions and teams to develop and implement regulatory CMC strategies as aligned across the business
- Develop and maintain relationships with health authorities and respond to health agencies, as needed.
- Provide regulatory CMC expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
- Lead and manage regulatory CMC cross-functional team members
- Serve as an expert in regulations, guidelines and precedents related to pharmaceutical development and CMC lifecycle management
Qualifications
- Advanced degree in a scientific discipline, preferably PhD or PharmD
- 10+ years of industry experience with 8+ years of experience working in regulatory affairs CMC for biologics
- Proficiency in regulatory (FDA, EMA, and ICH) guidelines
- Strong knowledge of current Good Manufacturing Practices (cGMP) and establishment registration requirements
- Experience in leading and writing CMC submissions is required
- Experience managing post-approval changes for commercial products
- Experience with post approval management of Quality by Design (QbD) filings, as well as experience with global filings highly desirable
- Sound understanding of CMC and QA-related issues
- Strategic thinking and strong problem-solving skills
- Strong interpersonal skills and the ability to communicate effectively with cross-functional teams
- Strong oral and written communication skills