Role Title: Associate Director/ Director Regulatory Affairs CMC
Location: Vacaville
Department: Regulatory Affairs
Reports to: CEO
FLSA Exempt
CORE VALUES
Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration
ROLE SUMMARY
In this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of our products. You will collaborate with cross-functional teams and regulatory authorities to help drive CMC regulatory strategies, submissions, and approvals.
ROLE RESPONSIBILITIES
- Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
- Provide strategic guidance on CMC aspects of regulatory submissions including INDs, BLAs, and ex-US submissions.
- Author and review of CMC-related regulatory documents for submissions including Module 2.3, Module 3, IMPD, CMC-related briefing documents, and other CMC-associated documents.
- Provide oversight and coordination for the development of CMC portions of regulatory authority submissions.
- Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
- Lead interactions with health authorities for CMC-related matters and prepare responses to inquiries.
- Proactively identify and mitigate potential CMC regulatory risks or roadblocks, developing contingency plans as needed.
- Participate in regulatory authority inspections and audits, as required.
- Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.
- Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.
- Drive continuous improvement initiatives related to regulatory processes, standards, and practices.
SKILLS & QUALIFICATIONS
- Bachelor’s degree preferably in a scientific field. An advanced degree and regulatory affairs certification are desirable.
- A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
- Background in biologics development is highly desirable.
- Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval and post-marketing regulatory CMC activities.
- Knowledge and experience with current Good Manufacturing Practices (cGMP), CMC regulations, and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
- Experience with CTD format and content.
- Ability to work independently and in a group setting and to interact effectively with different functional areas.
- Experience with US regulatory submissions; ex-US experience is desirable.
- Detail-oriented with a focus on quality and compliance.
- Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
- Strong demonstrated experience with Microsoft Word, Project, and authoring templates.
