- 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
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Associate Director Regulatory Affairs (Immune Health Institute) Job Profile ... Associate Director, Clinical Research Regulatory Job Description Summary he Associate Director of Regulatory Affairs will oversee regulatory … 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
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Novo Nordisk (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
- 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
- GRAIL (Durham, NC)
- …technology, and healthcare companies. For more information, please visit grail.com . The Associate Director of Global Regulatory Affairs & Safety serves ... + Experience of working in IVD, medical device, or pharma industries in regulatory affairs / quality roles with experience of regulatory submissions and… more
- Novo Nordisk (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
- Merck (Upper Gwynedd, PA)
- …reliable, and compliant medical products, practices and solutions to the world. The Associate Principal Scientist Regulatory Affairs supports products in the ... **Job Description** Our Regulatory Affairs team brings new medical...in preparing submissions, protocol review, and conducting research on regulatory guidances or competitive intelligence. The Associate … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Associate Director of Regulatory Affairs , you will lead regulatory activities for new product development, labeling ... This position reports to the Vice President of Global Regulatory Affairs . **Job Description** We are **the...Responsibilities:** + Work with internal teams including R&D, Marketing, Quality Assurance, and Operations to develop regulatory … 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
- Fresenius Medical Center (Tampa, FL)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions… 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
- Takeda Pharmaceuticals (Boston, MA)
- …global vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that… more
- LSI Solutions (Victor, NY)
- …with state-of-the-art devices. After all, our ultimate customer is the patient. POSITION TITLE: Regulatory Associate - Days 8am to 5pm SALARY RANGE: $85,000 - ... $95,000 JOB SUMMARY: The Regulatory Associate applies her/his experience, knowledge, organization...brochures, post-market clinical follow-up, and post market surveillance. All Regulatory Associates will also maintain full Quality … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Kelly Services (Sunnyvale, CA)
- …progress in the biotechnology realm. **Workplace:** Remote (USA) **Position Title:** Senior Regulatory Affairs Associate , New Product Development **Pay ... Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract...Critical review of study protocols and reports to assess quality , clearly identify gaps, and provide mitigations **Why Join… more
- Cook Medical (Bloomington, IN)
- …in fast paced situations. Qualifications - Bachelor's degree in a related field preferred; Associate 's degree in Regulatory Affairs ; or experience of such ... Overview The Regulatory Affairs Specialist I at Cook...opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA… more
- Novo Nordisk (Bloomington, IN)
- … liaison to clients and internal functional departments. Relationships Reports to: Associate Director, Regulatory Affairs Essential Functions + Review ... and help us make what matters. The Position The Regulatory Affairs department is accountable for the...update facility drug master file(s) + Prepare accurate and quality documentation for client regulatory submissions +… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more