Director, Global Regulatory Affairs CMC

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls. This pivotal role involves leading the development of regulatory strategies for complex products, ensuring compliance throughout their lifecycle. The ideal candidate will have extensive experience in biopharmaceuticals, strong communication skills, and a proven ability to manage teams and projects effectively. Join a dynamic environment that values innovation and compliance, and make a significant impact on product registration and management.

Qualifications

• 8+ years of experience in biopharmaceutical or related industries focused on GRA-CMC.
• Strong knowledge of pharmaceutical sciences and drug development.

Responsibilities

• Lead development and implementation of global CMC regulatory strategies.
• Manage daily delivery of regulatory activities for assigned CMC programs.

Skills

Regulatory Affairs

Project Management

Communication Skills

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 to ensure successful registration and lifecycle management of complex products. May lead individual teams (people manager).

You will be responsible for:

1. Leading the development and implementation of global CMC regulatory strategies for clinical and commercial products, serving as a primary project leader for submissions and compliance activities.
2. Providing strategic and operational global CMC regulatory direction for assigned projects, covering initial registrations and post-approval activities.
3. Managing daily delivery of regulatory activities for assigned CMC programs, including registrations, post-approval changes, portfolio growth, and compliance.
4. Developing proactive regulatory strategies for product lifecycle management, resolving complex issues, managing risks, and promoting regulatory innovation.
5. Leading teams for CMC meetings with regulatory authorities, discussing and defining regulatory requirements, and representing CMC in formal meetings.
6. Partnering with cross-functional teams including Regulatory Affairs, Manufacturing, Quality, and others.
7. Participating in GMP inspections and leading interactions with regulatory bodies.
8. Proposing policies, interpreting global regulations, and assessing their impact on business and development programs.
9. Contributing to regulatory initiatives promoting compliance, innovation, and talent development.
10. 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 a focus on GRA-CMC. Experience with various product types is desirable.
• Education: BA/BS in a scientific discipline; MS or Ph.D. preferred.
• Strong communication skills and ability to build relationships with stakeholders across functions.
• Broad knowledge of pharmaceutical sciences and drug development and manufacturing of biopharmaceuticals.

AstraZeneca values diversity and inclusion, welcoming applications from all qualified candidates and complying with non-discrimination laws.