- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for ... be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling , Policy and Intelligence. The position may be based in our Princeton, New… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and...Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation &… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on… more
- Repligen (Hopkinton, IA)
- …shift operations (M-F).The QC Inspector I will report directly to the QA/QC Director .This position is responsible to actively participate in the Repligen ISO 9001 ... label(s) to approved production materials according to the inventory part labeling specification. Requires demonstrated use of inspection tools (ie: Calipers,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... development and implementation of labeling content and strategy of multiple assigned products in...you will contribute:** With guidance from leadership: Management of Labeling Cross-Functional Teams + Independently leads Labeling … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... the development and implementation of labeling content and strategy of multiple products in various...and EU SmPC. **How you will contribute:** **Management of Labeling Cross-Functional Teams** + Leads Labeling cross-functional… more
- Merck (Rahway, NJ)
- **Job Description** **Associate Director , Business System Labeling Management** **Required experience and skills:** + Min. 5-10 years of experience with ... Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the development and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling … more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 6420 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee the… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... topics/ CSC agenda items + Actively leads communication of recommendations to labeling group/other stakeholders + Actively participates in meetings as required in… more
- Chiesi (Cary, NC)
- …is also responsible for providing input to risk management activities, managing the labeling control process, including generation of new labeling and changes to ... existing labeling , and submission of labeling information to regulatory authorities in the United States...Canada. + Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in… more
- Bausch Health (Bridgewater, NJ)
- …values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and post-approval/regulatory compliance ... key regulatory milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling… more
- Lundbeck (Deerfield, IL)
- Director Regulatory Affairs Alliance and Commercialization Requisition ID: 6530 Location: Deerfield, IL, US Do you want to join a team where the mission is ... Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Alliance and Commercialization, will oversee and lead… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Responsibilities:** The Senior Medical Director is delegated various responsibilities by the Medical Development AVP or ... management team in fulfilling corporate goals and initiatives. The Senior Medical Director will provide strong leadership and ability to influence, both within and… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director -Medical is delegated various responsibilities by the Associate Vice-president or equivalent ... the management team in fulfilling corporate goals and initiatives. The Senior Director -Medical will provide strong leadership, ability to influence, both within and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US… more
- Boehringer Ingelheim (St. Joseph, MO)
- …governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam member in ... + Responsible for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams as an RA sub… more
