- 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
- 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
- Merck (North Wales, PA)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Merck (North Wales, PA)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Organon & Co. (Plymouth Meeting, PA)
- …or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory ... will encompass late-stage development products and commercially approved compounds. The Associate Principal Scientist may also support project team goals and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Director ( Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & ... Controls (CMC), Network Project & Resource Management will provide regulatory CMC support, for Organon Network Projects. This position will lead the preparation, 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
- 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
- Merck (North Wales, PA)
- **Job Description** Under minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director ...all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS). +… 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
- 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