Job Description

This is what you will do:

The Director of Global Regulatory Affairs - Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for developing and implementing global CMC regulatory strategies to ensure successful registration and lifecycle management of complex products. May lead individual teams (people manager).

You will be responsible for:

• Lead the development and implementation of global CMC regulatory strategies supporting clinical and commercial products. Serve as primary project leader for CMC regulatory strategies, submissions, and compliance activities.
• Provide strategic and operational direction for global CMC regulatory documentation, covering initial registration and post-approval activities.
• Manage assigned CMC programs, including regulatory activities, portfolio growth initiatives, and compliance of commercial products.
• Develop proactive regulatory strategies for product lifecycle management, resolving complex issues and managing risks. Promote regulatory innovation and present strategies to management.
• Lead teams in preparing for meetings with regulatory authorities to discuss CMC requirements. Act as CMC representative in formal meetings and teleconferences.
• Partner with cross-functional teams including Regulatory Affairs, Manufacturing, and Quality.
• Participate in GMP inspections and lead interactions with regulatory authorities.
• Propose policies and interpret global regulations, maintaining awareness of legislation impacts.
• Contribute to regulatory initiatives supporting compliance, innovation, and talent development.
• Manage and develop junior staff as an accountable team leader.

You will need to have:

• At least 8 years of relevant experience in biopharmaceutical or related industry, with strong GRA-CMC background. Experience with various product types is desirable.
• BA/BS in a scientific discipline; MS or Ph.D. preferred.
• Excellent communication skills and ability to build relationships across functions.
• Broad knowledge of pharmaceutical sciences and drug development, especially biopharmaceutical manufacturing.

Date Posted: 19-Aug-2025

Closing Date: 29-Sep-2025

We are committed to an inclusive environment and encourage applications from all qualified candidates. Accommodations available for applicants with disabilities or special needs.

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