Senior Manager – Regulatory - Chemistry, Manufacturing, and Controls

Position Summary: 

The Senior Manager of Global Regulatory Chemistry, Manufacturing, and Controls (GRA-CMC) plays a pivotal role in implementation of global CMC regulatory strategies for the successful registration and lifecycle management of unique and technologically complex products. This role will influence complex projects and support responses to regulatory agency inquiries for Alexin’s commercial and investigational products.  

Primary Responsibilities: 

• Responsible for independently managing assigned CMC programs, including daily execution of plans, strategic activities, and compliance for clinical and commercial products.

• Oversee the development, coordination, and submission of CMC sections in Alexion’s registration dossiers, supplements, and renewals, including new country submissions and post-approval changes.

• Formulate global CMC regulatory strategies with minimal oversight and present them to Alexion management and core teams.

• Lead CMC project teams, ensuring clear project plans, monitoring progress, identifying critical paths, and developing contingency measures. Maintain clear communication with management and teams.

• Conduct research and analysis of regulatory documents, navigate complex issues, and facilitate regulatory innovation within project teams. Engage with Health Authorities and prepare necessary documentation.

• Collaborate with Regulatory Affairs, Manufacturing, Quality, and other partners, offering guidance and ensuring CMC documentation quality and compliance. Manage documentation filing and archiving in line with Alexion’s policies.

Qualifications

• A Bachelor’s degree in relevantscientific discipline with a minimum of 5 years of experience in Regulatory and/or Regulatory-CMC

• Relevant technical experience in biopharmaceutical or related experience in a scientific discipline with additional technical / project education or training

• Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.

• Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without accommodation,to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours