- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make ... Join our dynamic and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you will utilize your… more
- Ascendis Pharma (Princeton, NJ)
- …workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Novo Nordisk (Princeton, NJ)
- …Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs -...Affairs , Dietary Supplements This position reports to the Director , Regulatory Affairs and is based ... Summit, NJ **Travel %:** <10% **Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is responsible for developing regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... Here, you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS)… more
- Bristol Myers Squibb (Princeton, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- Sumitomo Pharma (Trenton, NJ)
- …role as directed such as content/slide development support, MSRC, PMRC, and Medical Affairs Booths. The Associate Director , Medical and Scientific ... a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Medical and Scientific Communications.** The Associate … more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …treatment of bipolar depression in adults as monotherapy and as adjunctive therapy. ** Associate Director / Director , Data Management** will oversee and provide ... Provide direction to study team to maximize compliance with regulatory requirements; review and suggest improvements to operating procedures...health related fields or closely related field + For Associate Director : Minimum of 7 years of… more
- Bristol Myers Squibb (Princeton, NJ)
- …partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and integrate one global ... Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing...in a cross-functional setting with the following teams: + Regulatory Affairs + Clinical Development + Biostatistics… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Associate Director will be responsible for supporting the development ... our team members are challenged and engaged with the broader matrix teams. The Associate Director will work with our Brand, Customer Experience, and Finance… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including at… more