Job Description

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

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