- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... and expanding mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations...customers such as: Clinical , Biostats, Legal, Medical Affairs , Commercial, Pharmacovigilance and regulatory vendors +… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
- Teva Pharmaceuticals (Weston, FL)
- Regulatory Affairs Associate II Date: Sep 23, 2024 Location: Weston, United States, Florida, 33331 Company: Teva Pharmaceuticals Job Id: 58068 **Who we are** ... to make a difference with. **The opportunity** Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate II (Weston, FL) to write, review, and… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- Globus Medical, Inc. (Audubon, PA)
- …so patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Associate assists in drafting, submitting and gaining ... data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus +… more
- University of Michigan (Ann Arbor, MI)
- Chief Pharmacy Officer/ Associate Dean for Clinical Affairs Apply Now **Job Summary** + Reporting jointly to the Chief Operating Officer of Pharmacy at ... CPO will also serve as a faculty member and Associate Dean for Clinical Affairs ...+ Ensure compliance with all local, state and national regulatory bodies. + Oversee and ensure systems for the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to five (3-5) years of experience in the pharmaceutical industry with experience in Regulatory Affairs . + Manager level: must have (1-3) years of experience in ... Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and...the pharmaceutical industry, preferably in Regulatory or Medical Affairs . + Specific experience… more
- AbbVie (Irvine, CA)
- …the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence ... https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports … 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 the project teams in this area. We are a hands-on culture so responsibilities will… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... the stages of team development. + Experience with developing regulatory strategies in coordination with clinical plans...with developing regulatory strategies in coordination with clinical plans and marketing objectives. + Experience with … 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
- Regeneron Pharmaceuticals (Troy, NY)
- …assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and ... review and approval of the compliance activities of the portfolio to confirm regulatory impact and associated submission requirements for clinical and commercial… more
- Kelly Services (Horsham, PA)
- Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist for a long-term engagement with one of our Global Pharmaceutical clients. ... Coordinator will help administer the day-to-day Regulatory Affairs operations as directed by the Associate ...Connect by cultivating internal collaboration with the R&D, Med Affairs , Clinical Affairs , Marketing and… more
- Astellas Pharma (Northbrook, IL)
- …activities. The individual will have interactions inside and outside of the Regulatory Affairs department, including with members of senior management, on ... of key stakeholders responsible for advertising and promotion review. 8. Collaborates within Regulatory Affairs to ensure that contents of promotional and sales… more
- Bristol Myers Squibb (Princeton, NJ)
- …database to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is responsible for content development, ... compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New… 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
- Merck (North Wales, PA)
- …Director/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Stryker (Redmond, WA)
- …More information is available at www.stryker.com . We are currently seeking an **Senior** ** Regulatory Affairs Associate ** to join our **Medical Division** , ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with...appropriate communication tools + Evaluate proposed pre- clinical , clinical , and manufacturing changes for regulatory filing… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. Join Takeda as an Associate Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device ... organization in the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device … more
- Kelly Services (Pacoima, CA)
- **Administrative Assistant - Regulatory Affairs Department** **Summary:** The Regulatory Affairs Administrative Assistant provides essential ... administrative support to the Regulatory Affairs Department of a flavor production...+ High school diploma required; secondary-level coursework or an associate 's degree is preferred. + 1-2 years of experience… more