Associate Director, Regulatory Labelling

Associate Director, Regulatory Labeling  

Overview

Alnylam is seeking an experienced labeling professional to join our labeling strategy team. This team is responsible for developing initial product label content and strategy through the Target Label Process (TLP). The ideal candidate will possess expertise in drafting label content and leading cross-functional teams within a larger development framework. In this role, you will work closely with labeling operations, compliance teams, and various internal stakeholders.

This position is hybrid onsite and remote working / open to remote working and will be located in the UK.

Key Responsibilities

• 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.
• Provide strategic guidance to Core Labeling Teams regarding new and revised labeling regulations, competitor labeling, and labeling trends.
• Review, Aassess and communicate impact of changes in health authority labelling legislation or guidelines on Alnylam’s products.
• Lead with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities.
• Lead 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.

Qualifications

• BS/BA degree (science or related discipline preferred), graduate degree desirable.
• Professional experience in biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications.
• Experience in Regulatory Affairs, including at least 2 years’ experience in a Labeling role responsible for developing and drafting prescribing information content.
• Familiarity with US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
• 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.
• Must be detail-oriented and able to multi-task and manage multiple projects.
• Skilled in written and verbal communications.