Job Description

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.

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