- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs , Regulatory Strategy ... to be a part of our Global Regulatory Affairs organization.In this role, you will...be responsible for planning, coordinating, and executing timely and high- quality submissions to the FDA.This is a hybrid position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...Affairs , Marketing, Legal, Quality , and other affiliates. External stakeholders include Healthcare professionals,… more
- Merck & Co. (Rahway, NJ)
- …close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key… more
- AUROBINDO (Dayton, OH)
- …experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several ... or related scientific discipline.Up to 2 years experience in pharmaceuticals Quality control Laboratory. Physical RequirementsLAB TECHNICIANS - Must be able to… more
- Merck & Co. (Rahway, NJ)
- …and Corrective/Preventative Actions (CAPAs)Previous background in quality control, quality assurance, auditing, or regulatory affairs .Ability to ... high quality data and clinical supplies. This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. 15 E- Work with the business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Public Affairs , Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, ... Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Affairs , Marketing, Legal, Quality , and other affiliates. External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. L ine management… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the ... of the Head of Quality / Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP… more
- Fujifilm (Bothell, WA)
- **Position Overview** ** Regulatory Affairs Associate - Bothell, WA** The Regulatory Affairs Associate requires application of regulatory ... and project management skills to oversee international registration of new products. As the Regulatory Affairs Associate , you will also work with … more
- 3M (Monroe, NC)
- Job Description: Job Title Certification and Conformance Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to ... a 3M career. The Impact You'll Make in this Role As a Certification and Conformance Regulatory Affairs Associate you will have the opportunity to tap into… more
- Actalent (Davis, CA)
- …QA experience. Job Description We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist with Quality Assurance (QA) experience to ... our commitment to quality . Responsibilities + Oversee the regulatory affairs process for new and existing diagnostic products, ensuring compliance with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …candidate to sit at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing ... create possible, together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC...major global CMC regulatory issues + Provides regulatory assessments for manufacturing changes and quality … more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... 5-7 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director, Analytical Regulatory Sciences, Systems & Operations in ... is a site based position located in Foster City, CA_** The Associate Director, Analytical Regulatory Science, collaborates with product development,… more
- Abbott (Lake Forest, IL)
- …and work experience. + **Minimum 10 years** of progressive work experience in regulatory affairs or a related discipline in the in vitro diagnostics/medical ... experience in medical devices and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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...to ensure attainment of governmental approvals. + Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact… more
