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Sr. Manager - Regulatory Affairs, Global Labeling
Ref No.: 18-15787
Location: Cambridge, Massachusetts
Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams as appropriate.
In collaboration with Global Regulatory Leads and Core Labeling Teams (CLTs):
Create, revise and maintain Company Core Data Sheets (CCDS) for Alnylam's products.
Develop labeling strategies and Target Label Profiles
Keep up-to-date on emerging clinical and other data, product safety, changes in manufacturing, and completion of post-marketing commitments and requirements for Alnylam products that may trigger changes to the CCDS and regional or local labeling.
Provide strategic guidance to Core Labeling Teams regarding new and revised labeling regulations, competitor labeling, and labeling trends.
Assess and communicate impact on Alnylam's products
Lead and/or provide support with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities.
Lead and/or assist with preparation of responses to labeling-related queries from health authorities.
Coordinate labeling activities (e.g. labeling supplements, new labeling development) with internal and external alliance partners as required.
Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling.
Support the growth of the Global Labeling function and help design/build systems and processes.

Familiarity with US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products
Must be detail-oriented and able to multi-task and manage multiple projects.
Skilled in written and verbal communications.