Hi,
Title: Associate Director Global Regulatory Affairs
Location: Cambridge MA
Hybrid position - 2 days onsite
Duration: Long Term
Industry: Biopharmaceutical / Pharmaceutical
Job Description
We are seeking an experienced Associate Director, Global Regulatory Affairs Labeling Lead to lead global labeling strategy and lifecycle management, with a primary focus on biologics . The ideal candidate will have strong experience developing Target Label Profiles (TLPs) and leading labeling strategies for Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and Summary of Product Characteristics (SmPC) updates. Experience with plasma-derived products is a plus.
The Labeling Strategist will lead cross-functional Label Working Groups , drive alignment across stakeholders, develop labeling recommendations, and present proposals to the Global Labeling Oversight Committee for review and endorsement. The role works closely with a team of four Labeling Strategists, Labeling Operations Leads, and the broader Global Regulatory Affairs organization.
...Now Hiring: Appointment Setters | New Call Center Opens in 7 Days!$18$27/Hour + Commission + Bonuses | Only 3 Spots Available (Metro) We're a multi-million dollar home improvement company with thousands of past customers and we need phone pros to help us book free...
...Hazardous Device Specialist / Public Safety Professional is a remote review track for evaluating AI outputs across hazardous device / public safety specialist operations workflows. Reviewers grade workflow correctness, policy adherence, and stakeholder fit; flag operational...
Public Trust: None Requisition Type: Regular Your Impact Own your opportunity to serve as a critical component of our nations safety and security. Make an impact by using your expertise to protect our country from threats. Job Description FRONT END ...
...Build Our Future Together The Director, Patent Attorney will act as legal counsel on matters related to the development, protection, and management of Regenerons valuable intellectual property pertaining to its manufacturing. The role will be responsible for patent...
...chain and forecasting/releasing methods/accuracy to suppliers.Responsible for overall supplier delivery performance.Enforce PPC data maintenance of the database.Ensure timely support of new models and build out activity. QUALIFICATIONS / REQUIREMENTS Bachelors...