- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Insmed Incorporated (San Diego, CA)
- …software for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is ... on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping… more
- Twist BioScience (South San Francisco, CA)
- …teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance, and R&D. The Director will serve as the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... differentiation.Collaborate with our Global Marketing, Clinical Development, and Government Affairs on the go-to-market strategy for the preclinical indication and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer… more
- Pall (Miami, FL)
- …and innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director , Global Regulatory Affairs provides management of all aspects of ... the development and commercialization of novel liver drugs including quality , preclinical and clinical areas of drug development. This...industry with a minimum of 8 years in Global Regulatory Affairs , experience with major Health Authority… more
- Bausch Health (Bridgewater, NJ)
- Director , Regulatory Affairs (Global Labeling) Job Location: Bridgeport, Connecticut, USA | Danbury, Connecticut, USA | Fairfield, Connecticut, USA | ... CCDS and USPI documents for new products. Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry… more
- Atrium Medical (Hudson, NH)
- …for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director . Assists the Regulatory ... for domestic (510(k)/IDE/PMA) and international submissions/registrations. Ability to represent Regulatory Affairs to other departments. For immediate… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products and compounds in ... days per week on average. Position Summary The Associate Director , Regulatory CMC, is responsible for contributing...least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us. The Associate Director , WW Medical Cell Therapy Autoimmune, LCM/Pan-Indication, will report to ... When appropriate, they will also support the execution of BMS sponsored Medical Affairs trials, and assist in the evaluation and support of collaborative and… more
- AbbVie (North Chicago, IL)
- … compliance, and contributes to the overall success of drug/device development programs. Associate Director , Safety, Medical & Regulatory Quality is part of ... the R&D Quality Medical Affairs (MA) QA team which provides independent ...Regulatory Agency inspections. The role reports to the Director , Safety, Medical & Regulatory Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA ... stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
- Vanderbilt Health (Nashville, TN)
- …through preeminent programs in patient care, education, and research. Organization: Quality Admin Job Summary: The Associate Director supervises, coordinates ... with MLS (ASCP) credentials with large hospital laboratory experience. The VUMC Quality Administration Laboratory Department is in need of a Associate Director… more
- Revolution Medicines (Redwood City, CA)
- …launches. Cross-Functional Coordination Facilitate collaboration between Global Medical Affairs , Clinical Development, Biostatistics, Market Access, Regulatory , ... Opportunity: As a key leader within the Medical Excellence function, the Director , Project Management Integrated Evidence Planning (IEP) & Health Economics and… more
- Corcept Therapeutics (Redwood City, CA)
- …shift in the way we understand and treat disease. The Associate Director , Scientific Publications, will provide expert scientific and medical writing support, ... focusing on publication strategy and execution for Oncology Medical Affairs -led publications in tandem with Clinical Development-led publication strategy and… more
- Emergent Biosolutions (Gaithersburg, MD)
- … Affairs , Government Affairs , Market Access, Competitive Intelligence, and Regulatory Affairs . A global marketing background is essential, and experience ... products designed-to protect and enhance life. I: Job Summary The Senior Director , Global Franchise Lead is responsible for leading commercial development and… more
