Summary: A global R&D organization is actively seeking an experienced CMC professional to join the groundbreaking work being developed in their Greater Boston location. You will be responsible for being an individual contributor to all phases of the Regulatory Affairs CMC submission.
The Associate Director Global Regulatory Affairs CMC will be responsible for…
- Contributing independently for assigned regulatory submissions in several phases of the clinical development.
- Facilitating interactions with global regulatory agencies for CMC related topics.
- Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
- Identify and mitigate regulatory risks associated with biologic product development, providing strategic recommendations to senior management.
- Represent the company in interactions with regulatory agencies, ensuring clear and effective communication and advocating for regulatory approvals.
- Provide subject matter expertise in biologics CMC regulatory affairs, including monoclonal antibodies, vaccines, and other biologic modalities.
The Associate Director Global Regulatory Affairs CMC should have the following qualifications...
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 8+ years of regulatory Affairs CMC
- Extensive experience with BLA processes and and life cycle submissions
- Experience with analytical development
- Strong knowledge of global regulatory requirements for biologics, including FDA, EMA, and ICH guidelines.
- Regulatory affairs certifications (e.g., RAC) are desirable.