Director, Global Regulatory Affairs CMC

AstraZeneca; Boston (MA); On-site; USD 130,000 - 160,000; Full time

Job summary

A leading company is seeking a Director of Global Regulatory Affairs CMC to develop and implement regulatory strategies for complex products. The role involves managing CMC programs, leading teams, and collaborating with various departments to ensure compliance and innovation. Candidates should have extensive experience in biopharmaceuticals and strong communication skills.

Qualifications

• At least 8 years of relevant experience in biopharmaceutical or related industries.
• Experience across diverse product types.

Responsibilities

• Leading the development and implementation of global CMC regulatory strategies.
• Managing assigned CMC programs and overseeing daily regulatory activities.
• Collaborating with cross-functional teams including Regulatory Affairs and Manufacturing.

Skills

Communication

Regulatory Strategy

Risk Management

Education

BA/BS in a scientific discipline

MS or Ph.D.

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 leading to successful registration and lifecycle management of complex products. May lead 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/products, covering initial registrations and post-approval activities.
• Managing assigned CMC programs, overseeing daily regulatory and strategic activities, including registrations, post-approval changes, portfolio growth, and compliance.
• Developing proactive regulatory strategies for global CMC product lifecycle management, resolving complex issues, managing risks, and promoting regulatory innovation.
• Leading CMC meetings with regulatory authorities, discussing and defining regulatory applications, and acting as a representative in formal meetings and teleconferences.
• Collaborating with cross-functional teams including Regulatory Affairs, Manufacturing, Technical Services, and others.
• Participating in GMP inspections and leading interactions with GRA-CMC.
• Proposing policies and interpreting global regulations, assessing their impact on the business.
• Contributing to regulatory initiatives that promote compliance, innovation, and talent development.
• Managing 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 experience across diverse product types. Other relevant pharmaceutical industry experience is also considered.
• Education: BA/BS in a scientific discipline; MS or Ph.D. preferred.
• Strong communication skills and ability to build relationships across functions.
• Broad knowledge of pharmaceutical sciences and drug development/manufacturing processes.

Date Posted: 07-May-2025

Closing Date: 29-May-2025

Alexion is an Equal Employment Opportunity and Affirmative Action employer committed to diversity and inclusion. Reasonable accommodations are available upon request.