Associate Director/ Director Regulatory Affairs CMC (Vacaville) Job at Polaris Pharmaceuticals Inc., Vacaville, CA

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  • Polaris Pharmaceuticals Inc.
  • Vacaville, CA

Job Description

Associate Director/ Director Regulatory Affairs CMC

1 day ago Be among the first 25 applicants

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
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Job Tags

Full time,

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