- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Merck & Co. (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... regulatory guidance and strategy to CMC sub-team and G- RA teams along with other functional teams leading to...guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations… more
- Merck & Co. (Rahway, NJ)
- …communications with staff, colleagues across CMC development, Quality Assurance, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper ... and vaccines from discovery through development and commercial launch.The Executive Director reports to the Associate Vice President, Analytical Enabling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...strategy. Serve as the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Merck & Co. (Rahway, NJ)
- …GCTO ( Global Clinical Trial Operations) country operations, finance, regulatory affairs ,-pharmacovigilance, legal and regional operations, HQ functional ... Job DescriptionWith support of Sr CRA (Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a… more
- Takeda Pharmaceuticals (Columbus, OH)
- … Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory...changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues… more
- Takeda Pharmaceuticals (Columbus, OH)
- … requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader (1 of 2) in ... Associate Director , Global Labeling...experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the ... job** The Associate Director , US Advertising and Promotion serves...get started? **Main responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo)… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the ... job** The Associate Director , US Advertising and Promotion serves... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- Bristol Myers Squibb (Madison, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead ... MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements**… more
- Astellas Pharma (Northbrook, IL)
- ** Associate Director , Global HEOR** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... /regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs , and Market Access. **Essential Job Responsibilities:**… more
- Integra LifeSciences (Princeton, NJ)
- …headway to help improve outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director , Global Marketing - Surgical Reconstruction, TT ... and evaluations + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the ... RA leadership team representative. + Responsible for the global regulatory strategy for UCC products +...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Astellas Pharma (Northbrook, IL)
- …decision should be elevated to upper management for further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ... Sr Director or Director of Promotion Review within US Regulatory Affairs . This individual must successfully influence and collaborate with individuals… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Advertising and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
