Polaris Pharmaceuticals Inc.
Associate Director/ Director Regulatory Affairs CMC
Polaris Pharmaceuticals Inc. - Vacaville, CA, US, 95688
Work at Polaris Pharmaceuticals Inc.
Overview
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Overview
Associate Director/ Director Regulatory Affairs CMC
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Role Title: Associate Director/ Director Regulatory Affairs CMC
Department: Regulatory Affairs
Reports to: CEO
FLSA Exempt
Salary Range- $170K-$210K
CORE VALUES
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 aligned with product development and registration plans.
- Provide strategic guidance on CMC aspects of regulatory submissions including INDs, BLAs, and ex-US submissions.
- Author and review CMC-related regulatory documents for submissions, such as Module 2.3, Module 3, IMPD, briefing documents, and other CMC-related documents.
- Oversee and coordinate the development of CMC portions of regulatory submissions.
- Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements. Provide guidance and support to manufacturing, QA, and R&D teams.
- Lead interactions with health authorities for CMC-related matters and prepare responses to inquiries.
- Identify and mitigate potential CMC regulatory risks, developing contingency plans as needed.
- Participate in regulatory inspections and audits when required.
- Review and approve CMC regulatory documentation, ensuring compliance.
- Support post-approval CMC commitments and post-marketing activities.
- Drive continuous improvement in regulatory processes, standards, and practices.
SKILLS & QUALIFICATIONS
- Bachelor’s degree in a scientific field; advanced degree and regulatory certification are desirable.
- 6-10 years in biotech industry with 4-5 years in Regulatory Affairs CMC.
- Background in biologics development is highly desirable.
- Experience with global regulatory submissions (IND, CTA, BLA, MAA) and post-approval CMC activities.
- Knowledge of cGMP, CMC regulations, and ICH guidelines.
- Experience with CTD format and content.
- Ability to work independently and collaboratively across functions.
- US regulatory submission experience; ex-US experience is a plus.
- Detail-oriented with a focus on quality and compliance.
- Strong project management skills and ability to handle multiple projects.
- Proficiency with Microsoft Word, Project, and authoring templates.
Seniority level
- Director
Employment type
- Full-time
Job function
- Quality Assurance
Industries
- Pharmaceutical Manufacturing