- The Mount Sinai Health System (New York, NY)
- **JOB DESCRIPTION** International Center for Health Outcomes and Innovation Research (InCHOIR) is a clinical and data coordinating center with an interdisciplinary ... faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety and… more
- AbbVie (Mettawa, IL)
- …and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and ... (risk minimization activities / safety surveillance activities). Works closely with international marketing and commercial teams to provide strategic medical input… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...+ reviews and leads preparation of IMPD to support international CTA submissions. + oversees preparation of regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Eurofins (Centennial, CO)
- …of quality and access to innovation across all the regions we serve. International Regulatory Affairs Coordinator responsibilities include, but are not ... to, the following: + Under the direction of the Director of Regulatory Affairs and...accreditation, certification and/or application processes of current and new International Regulatory Bodies (eg Australian Therapeutic Goods… more
- Abbott (Abbott Park, IL)
- …place to work for diversity, working mothers, female executives, and scientists **Position: Director , Regulatory Affairs , LATAM** The Director , Abbott ... also have access to: + Career development with an international company where you can grow the career you...individual may also contribute to planning, directing and coordinating regulatory affairs activities related to products worldwide.… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... also have access to: + Career development with an international company where you can grow the career you...Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... standards + Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... also have access to: + Career development with an international company where you can grow the career you...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with… more
- Abbott (Lake Forest, IL)
- …19 years) Preferred **Experience/Background** + Minimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device ... experience in medical device and thorough knowledge of clinical research and/or regulatory affairs preferred + Experience working in a broader enterprise/cross… more
- Ascendis Pharma (Palo Alto, CA)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …team advancing Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs . The incumbent will ... on regulatory strategies for product development. This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic… more
- AbbVie (Irvine, CA)
- …incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, ... Follow Allergan Aesthetics on LinkedIn. Job Description The Associate Director of Regulatory Innovation supports regulatory … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The 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...If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... greater United States, preferably East Coast** **Summary:** Responsible for providing regulatory strategic support for global regulatory activities for… more
- Bureau of International Labor Affairs (Washington, DC)
- …critical issues, which would impact ILAB, Department, and other governmental agencies' international policies and programs. Advises the OCFT Director , the Deputy ... associated with international organizations, problems, or other aspects of foreign affairs In addition to meeting the basic requirement above, to qualify for… more
- Abbott (Princeton, NJ)
- …operational performance. Our location in Princeton, NJ currently has an opportunity for a Director of Medical Affairs , Americas. The Director of Medical ... executives, and scientists. **What You'll Work On** + Reporting directly to the Sr. Director , Global Medical & Scientific Affairs (GMSA), Abbott Point of Care +… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... Medical Director , Gastroenterology Therapeutic Area - Medical Affairs...generation and dissemination. * Contribute to the preparation of regulatory submissions and interactions with Health Authorities (and particularly… more