Dir, Regulatory Affairs

Alkermes • Waltham, MA

111d

About The Position

Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary.

Responsibilities

• Lead the generation of new core labeling documents.
• Revise existing core labeling documents.
• Collaborate with cross-functional subject matter experts and Global Regulatory Leads (GRLs).
• Manage multiple assigned products, including early and late-stage assets.
• Partner with Regulatory, Clinical Development, Drug Safety, and Quality personnel.
• Support development and maintenance of labeling content.
• Contribute to health authority negotiations as necessary.

What This Job Offers

• Career Level: Senior
• Number of Employees: 1,001-5,000 employees