- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs… more
- Merck & Co. (Rahway, NJ)
- … regulatory systems and technologies to support the operational needs of the regulatory affairs department. The incumbent will be knowledgeable and work in ... update regulatory changes and communicate relevant updates to the regulatory affairs team as necessary. Implement and maintain processes to ensure compliance… more
- Aequor (Bothell, WA)
- Job Title: Regulatory Affairs Contractor Work Location: Bothell, WA 98021 - Hybrid role - 3 days onsite , 2 days remote - locals only Duration: 12 months ... Request-ID#33378-1 Job Description: POSITION SUMMARY: Team is seeking a Regulatory Affairs Contractor to contribute to the development and execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, Exela's contract ... and submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on change controls, quality holds, on-boarding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities include but are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, ... - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, International Operations, NN International Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... 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
- Genmab (Plainsboro, NJ)
- …US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional ... affairs strategies.Familiar with the US healthcare system, including regulatory requirements, payer landscape, etc.Presented customer focus orientation; product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, especially with Medical Directors, Marketing, Marketing Operations, Legal, Regulatory Affairs and externally with agencies. Represent Medical ... external agencies. Key internal relationships include Marketing Operations, Marketing, Legal, Regulatory Affairs , Medical Affairs , Convention Marketing and… more
- Insmed Incorporated (San Diego, CA)
- …with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... and Risk-Evaluation and Mitigation Strategies (REMS). Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs Labeling position will provide Regulatory support ... preferredExperience QualificationsExperience in the pharmaceutical industry4 or More Years direct regulatory affairs experience4 or More Years in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the Global ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Affairs (MAPA), Portfolio Strategy, Insights and Analytics, Commercial Excellence, Legal, Regulatory Affairs , and other relevant NNI departments to ensure ... team and extended NNI teams Product Evolution Oversee product strategy and regulatory activities related to life cycle management efforts Promotions Develop and… more
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