As the Associate Director of Regulatory CMC, reporting to the Director of Regulatory CMC, you will be pivotal in managing the development and submission of regulatory filings for gene therapy projects both domestically and internationally. You will be responsible for devising and implementing cutting-edge CMC regulatory strategies to facilitate regulatory submissions. This will require close collaboration with the CMC team, internal technical functions, contract manufacturing organizations, and external consultants and collaborators.
Responsibility:
- Lead the strategic direction for regulatory CMC activities related to gene and cell therapy products, supporting both early and late-stage development efforts.
- Oversee the preparation of high-quality clinical trial applications for the US, EU, and other global markets.
- Work in tandem with technical teams and regulatory project managers to ensure timely submissions.
- Handle responses to CMC queries from health authorities independently.
- Lead global negotiations with regulatory agencies for late-phase clinical development and marketing applications.
- Assist with regulatory agency interactions during GMP and pre-approval inspections.
- Collaborate innovatively with technical teams to drive manufacturing and analytical development strategies.
- Identify and articulate regulatory opportunities and challenges to the technical and clinical regulatory strategy teams, and develop strategies to optimize regulatory outcomes.
- Contribute to the enhancement of internal regulatory processes and standards.
- Ensure compliance with regulatory guidelines through timely assessment of change controls and deviations, and completion of quality trainings.
Qualifications:
- Master's degree in life sciences (biochemistry, chemistry, biology, or a related pharmaceutical field); a PhD is preferred.
- 6-8 years of relevant experience in the biopharmaceutical industry, with at least 5 years focused on CMC Regulatory Affairs for biologics.
- Significant experience with cell therapy, gene therapy products, or mRNA-based therapeutics is highly preferred.
- Proven track record in leading regulatory CMC programs/projects (Phase I/II and Phase III IND/CTA, MAA/BLA) and familiarity with non-viral or viral vectors.
- Experience in managing interactions with regulatory health authorities and submitting CTA/IND and BLA/MAA filings, particularly related to gene therapy.
- In-depth knowledge of GMP, drug and biologics development regulations, and guidelines, including ICH, FDA, and EMA standards.
