- 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
- 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Bristol Myers Squibb (Madison, 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
- J&J Family of Companies (Raritan, 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
- AbbVie (Florham Park, NJ)
- …level will be determined by the qualifications listed below. Purpose: The Associate Scientific Director , Psychiatry Pipeline role provides medical and scientific ... statistics, regulatory , etc) as they relate to on-going medical affairs projects. May assist as consultant/liaison with other corporations when working under… 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
- AbbVie (Florham Park, NJ)
- …standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in the ... level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational… more
- AbbVie (Florham Park, NJ)
- …onsite) in Florham Park, NJ preferred. Will consider remote candidates. The Associate Scientific Director provides medical and scientific strategic and ... operational input into core medical affairs activities such as: health care professional and provider...regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison… more
- System One (Florham Park, NJ)
- …regions, and provide insights to the Senior Director and Associate Director . + Contribute to managing regulatory risks and opportunities related to QOL ... Senior Manager, Regulatory Affairs Strategy - Contractor Must...(QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to… more
- Bristol Myers Squibb (Madison, 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
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Advocacy** The Associate Director , Policy Advocacy serves as the senior expert ... change in support of the company's business objectives. The Associate Director will proactively research and stay...with at least 10 years' experience in international government affairs with a preference for candidates with experience in… more
- Merck (Rahway, NJ)
- **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
- 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
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Strategy and Capabilities** The Associate Director , Policy Strategy and ... Executive Director , Policy Development & Strategy. The Associate Director will develop and maintain the...with at least 5 years' experience in international government affairs roles in governments, think tanks, or business associations… 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