Senior Manager/Associate Director, Regulatory Affairs CMC

2 weeks ago

Vacaville, United States Polaris Group Full time

Role Title:

Senior Manager/Associate Director, Regulatory Affairs CMC Department:

Regulatory Affairs 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.

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