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. The role may involve leading individual teams (people manager).

You will be responsible for:

• Leading the development and implementation of global CMC regulatory strategies supporting clinical and commercial products. Serving as a primary project leader for CMC regulatory strategies, submissions, and compliance activities.
• Providing strategic and operational global CMC regulatory direction and documentation for projects, covering initial registration and post-approval activities.
• Managing assigned CMC programs, ensuring timely delivery of regulatory activities, including registration, post-approval changes, and compliance.
• Developing proactive regulatory strategies for product lifecycle management, resolving complex issues, and managing risks.
• Leading interactions with regulatory authorities for CMC meetings and discussions, including acting as a CMC representative in formal meetings.
• Partnering with cross-functional teams within the company, including Regulatory Affairs, Manufacturing, and Quality.
• Participating in GMP inspections and leading interactions with regulatory agencies.
• Proposing policies, interpreting global regulations, and assessing their impact on the business.
• Contributing to regulatory initiatives that promote compliance, innovation, and talent development.
• Leading and developing junior staff as an accountable team leader.

You will need to have:

• At least 8 years of relevant experience in biopharmaceutical or related industries, with a strong background in GRA-CMC. Experience with various product types is desirable.
• Educational background: BA/BS in a scientific discipline; MS or Ph.D. preferred.
• Excellent communication skills, capable of engaging with multiple stakeholders in a cross-functional environment.
• A broad understanding of pharmaceutical sciences and drug development, especially in biopharmaceutical manufacturing.

Date Posted: 19-Aug-2025

Closing Date: 29-Sep-2025

We promote an inclusive environment and welcome applications from all qualified candidates. Accommodations are available upon request for applicants with disabilities.

Job Tags

Similar Jobs