- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the...Phase 2 to Phase V, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis,… more
- Merck & Co. (Rahway, NJ)
- …development strategy , study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Merck & Co. (Rahway, NJ)
- …barriers to reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn ... the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion ... to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual is...preparedness for the respective MA inspections in alignment with regulatory and company strategy . Act as management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... pull you in? Are you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical role in shaping the future strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers....you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data ... you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on the obesity… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (50% hybrid) Type: 12-month contract Must haves: + Must be local for ... fully remote is NOT an option. + Must have regulatory strategy experience in IND/NDA development, not...development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in… more
- Bayer (Whippany, NJ)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison** The Director US ... TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Regulatory Affairs Liaison,...the customer and stakeholders. + Develops and enacts US regulatory strategy (clinical/labeling) and outcomes on key… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care...for the development of direct reports + Contribute to strategy , planning, and execution of the device regulatory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within Gilead's ... Global Regulatory Affairs organization and acts as a...Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory … more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Bausch Health (Bridgewater, NJ)
- …our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy , to deliver high quality ... CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry… more
