- 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
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary interface… 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
- J&J Family of Companies (Titusville, NJ)
- …Innovative Medicine is recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the ... can reach their potential. At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for the development,… 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
- 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
- US Tech Solutions (Titusville, NJ)
- …including: + Partnership across Medical Affairs , RW V&E, JRD, Brand Marketing, Regulatory Affairs , Global Medical Affairs , New Business Development, J&J ... This title in the market could be a Medical Affairs Associate or Specialist + This role...Doctorate, PhD, or PharmD + Will be monitoring trials, regulatory affairs , etc with competition + Will… more
- Sumitomo Pharma (Trenton, NJ)
- …Medicine, and Commercial launch strategy and guide the tactical implementation of Medical Affairs plans. The Associate Director will also collaborate with ... Senior Manager, Medical Strategy (Oncology) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy.… 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
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Sciences - Ophthalmology - 2406190657W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... Learn more at https://www.jnj.com/. Johnson & Johnson is recruiting for an ** Associate Director , Clinical Project Scientist - Ophthalmology** to be located… more
- Amicus Therapeutics (Princeton, NJ)
- …with Technical Operations, Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is ... Associate Director , External Quality Lead (Small...Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance of outsourced… 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
- Ascendis Pharma (Princeton, NJ)
- …grow and develop their skills. Ascendis Pharma is looking to hire an experienced Associate Director , Market Access, Payor and Channel Marketing to join our team. ... such as Pricing, Contracting & Distribution (PCD), Brand Marketing, Medical Affairs , Finance, Legal, other Market Access colleagues, external customers and agency… more