- Aequor (Thousand Oaks, CA)
- Regulatory Affairs Associate - CW Remote EST preferred. Ideal candidate: BS &plus 4YOE or MS and around 2 YOE. Preferred or pharma experience. Veeva ... backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (eg… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for… 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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… 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 ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategic Partner Engagements Team. Key internal NNI relationships include Medical Affairs therapy areas, other Clinical, Medical, Regulatory (CMR) functions, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Associate Director of Medical Data Strategy and Analytics plays… more
- Novo Nordisk Inc. (Omaha, NE)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Board, Patient Marketing, Managed Markets, Trade, Corporate Communications, Legal, Regulatory , Medical Information and Medical Affairs . External relationships ... planning and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention plan… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety… more
- 3M (Maplewood, MN)
- …or military experience to a 3M career. The Impact You'll Make in this Role As a Senior Regulatory Affairs Associate , you will have the opportunity to tap ... Job Description: Job TitleSenior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career… more
- Boehringer Ingelheim (Ridgefield, CT)
- …lives? Boehringer Ingelheim is seeking a dedicated and innovative Director/ Senior Associate Director, Global Regulatory Affairs CMC for Chemical products ... to the continuous improvement of processes and standards within Regulatory Affairs . If you have a strong...regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …leadership to business partners, the Associate Director of Process Excellence Regulatory Affairs , and execute regulatory strategies and objectives for ... **Job Description Summary** The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising...compliant manner. As part of the Regulatory Affairs team, you will report to the Senior… more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US ... strategic regulatory guidance to facilitate efficient and compliant drug development...Administration + Provide analysis, advice and guidance on US regulatory strategies. + Provide expertise on regulatory … more
- Takeda Pharmaceuticals (Columbus, OH)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... to the world. **How you will contribute:** + The Associate Director, GRA Labeling Compliance, is responsible for the...global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and implementing… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at...**Or** Bachelor's degree and 6 years of experience in regulatory or pharmaceutical drug development **Or** Associate 's… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional...senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle… more
- American Heart Association (Washington, DC)
- …your career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy ... (hybrid work arrangements available. Under the direction of the Director, Federal Regulatory Affairs , you would be responsible for monitoring, analyzing, and… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the ... Senior Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for… more
