- Genmab (Blawenburg, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US Market and Commercial Teams (and others) and ... is essential to fulfilling our purpose. Job Description - Director , Digital Assets, Information Security Position Summary The ...Genmab Security Operations Team Business leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM… more
- Genmab (Blawenburg, NJ)
- …advisory boards, patient advocacy groups), internal stakeholders (eg, Research, Safety, Regulatory , Medical Affairs , Commercial), and internal decision boards ... to fulfilling our purpose. The Role: The Senior Medical Director supports Oncology Clinical Devlopment. Responsibilities: Oversee clinical program including… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. + Gain endorsement from ... product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Merck (Rahway, NJ)
- …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...regulatory strategy for their assigned products, in order to optimize… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … agencies. You will lead and oversee the Global Regulatory Affairs (GRA) Labeling organization, inclusive of labeling strategy and labeling operations ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global… more
- Bausch Health (Bridgewater, NJ)
- …**KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on the Regulatory ... standards and other best practices guidelines + Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence + Provide… 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 ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … strategy . + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on cross-functional/cross-regional sub-teams ... TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional ...Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… more
- Merck (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets. + Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own. + Lead… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... be determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is...compliance with regulatory and ethical standards in all medical … more
- AbbVie (Florham Park, NJ)
- …and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Provides scientific and ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more