- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) ... provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company goals.… more
- BioAgilytix (Durham, NC)
- …while you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the ... and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.Essential… more
- DivIHN Integration Inc (Columbus, OH)
- …product experiences, in-depth investigation of medical adverse events and works with Medical Affairs , Clinical, and Regulatory Affairs in the preparation of ... device or Pharma As an individual contributor, with guidance from the manager /team, functions to support the medical safety team by collecting, assessing, processing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to...on external regulatory initiatives Works with Group Manager to maintain surveillance of regulatory environment… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Aequor (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... Sigma method and project management experience. The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role ... in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical… more
- Aequor (NJ)
- …Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors, CRO's, IRT ... 100 % remote Manager prefers local candidates (will consider non local...phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout NNI and at external agencies. Key relationships include Marketing, Legal, Regulatory Affairs , and Medical Affairs . Other relationships may ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...include Convention Marketing and Sales Training. The Manager may represent Medical on PRB working group, brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... HR, and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological… more
- Arthrex (Naples, FL)
- …Treat Their Patients Better (TM) . We are currently seeking a motivated International Regulatory Affairs Specialist I to join our collaborative team at our ... regulatory strategies and offer solutions, as applicable. Partner with in-country Regulatory Affairs teams to provide regulatory support for changes… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & Marketing, and Legal ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Arthrex (Naples, FL)
- …in orthopedics. Arthrex is actively searching for a Sr. Project Manager , Program Manager - Regulatory Affairs who is responsible for managing and ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs . Develops project objectives by reviewing project proposals… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including but not limited investor relations, RD, global and US medical affairs and marketing, legal, regulatory and congress planning Qualifications: Successful ... candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree in relevant discipline required Experience Qualifications- 4 or More… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained. Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Main purpose of...role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support… more
