- 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
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... pertaining to prescription medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs ** , works out of ... reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...and mentor regulatory professionals. **Premarket:** + Approve regulatory filing strategies based on proposed preclinical, clinical… more
- Bausch Health (Bridgewater, NJ)
- …itwhere 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
- GRAIL (Washington, DC)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Development and Commercialization process. + Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing ... around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... Project Management & Program management, and external cross functional teams, Clinical , non- clinical and regulatory leadership. + Drive adherence… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Generalist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Generalist** **for** our client a leading medical ... from subject matter experts in nonclinical, clinical , and medical affairs . + Provide operational and administrative regulatory writing (cover letters,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …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 risks. + Lead and Manage Global Submission Activities: Oversee… more
- Johns Hopkins University (Baltimore, MD)
- …Dean of Clinical Affairs (VDCA)/President of the CPA (dual role), the Associate Dean of Clinical Affairs (ADCA), and the Executive Director, Faculty ... We are seeking a **_Sr. Director, Office of Vice Dean of Clinical Affairs & Faculty Practice Plan_** for the Office of Vice Dean of Clinical Affairs … more
- University of Colorado (Aurora, CO)
- ** Associate Dean for Faculty Affairs Open...and the Dean's Office, including with the Office of Clinical Affairs , Office of Research, Office of ... the Dean, Office for the Faculty Experience** **Job Title: Associate Dean for Faculty Affairs ** **Open Rank-...with the Office of Legal Counsel, human resources, and regulatory bodies to develop, revise, and implement faculty policies… more
- AbbVie (Mettawa, IL)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + ... Has overall responsibility for oversight of the Medical Affairs -led clinical studies, monitoring overall study integrity and review, interpretation and… more
- Amgen (Washington, DC)
- …alongside other innovative, driven professionals in this meaningful role. **Companion Diagnostic Regulatory Affairs Manager** **Live** **What you will do** Let's ... or Regulatory experience **Preferred Qualifications:** + MS Degree + Degree in Regulatory Affairs , Life Sciences, or Engineering + 6 plus years of experience… more
- Novo Nordisk (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... About the Department The Clinical , Medical and Regulatory (CMR) department...relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …exploring candidates with a less traditional background. **Job Description** We are seeking an Associate for our North America Medical Affairs team. This is a ... Serve as medial lead for meetings or responses to regulatory agencies * Work closely with Head, Pharmacovigilance and...agencies * Work closely with Head, Pharmacovigilance and Medical Affairs to ensure standards of medical & clinical… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and ... Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, acquiring… more
- Takeda Pharmaceuticals (Boston, MA)
- …in coordination with relevant cross-functional teams (including members of medical affairs , clinical development, and outcomes research; global, regional, or ... and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology.… more
- Abbott (Lake Forest, IL)
- …Abbott's diagnostics instruments, providing lab results for millions of people. An ** Associate Director at the Medical, Clinical & Scientific Organization ... (MCSO)** at Abbott is a senior-level executive who manages clinical strategy. They work to improve health management by ensuring resources and keeping the … more
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