- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be responsible for ... of Instruction for Use (IFU) documents and Device Container Labeling content in line with US and EU standards...and EU standards and guidelines. Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible 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 various stages of drug development, which may… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …BMS standards. **Key responsibilities** The position reports to the Associate Director (PDQ) - Packaging & Labeling , with job responsibilities that include ... but are not limited to: + Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs), and releases those found in compliance into SAP and Veeva(R) Infinity system as applicable. Responsibilities… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... key regulatory milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling… more
- Boehringer Ingelheim (St. Joseph, MO)
- …such as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the establishment… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **Objective:** Under the direction of the Director or Sr. Director , ODPD, the Assoc. Director is responsible ... manufacturing process optimization, scale up and QbD are required. The Assoc. Director actively manages and oversees Takeda employees and contractors to achieve… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** ... plans with commercial and development plans + Develop target labeling and co-lead the cross-functional labeling team....Develop target labeling and co-lead the cross-functional labeling team. + Ensure consistent positions are presented in… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical Neur opsychiatry position works in the ... manage integration points across US functional and commercialization areas to ensure alignment. The Associate Director will report to the Senior Director , US… more
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