- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... (fast track, RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies, non-interventional studies, Compassionate Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality ... diseases and immune disorders. Job Summary: Reporting to the Sr . Director , Medical Affairs QA,...the Quality organization at senior levels. The Director plays a pivotal role in regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and… more
- Merck & Co. (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... manage significant cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays a critical role in driving… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Eisai, Inc (Cincinnati, OH)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...with Medical Affairs and Clinical Development teams for support of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- buyer (New York, NY)
- …Other duties as assigned by the Director , Senior Director or Chief Compliance & Regulatory Officer.Minimum Qualifications* Bachelor's degree required; ... to regulations. The position is accountable for supporting the Director of State Regulatory Guidance and will...and* 5+ years of Regulatory Affairs work experience; or* A satisfactory… more
- Inside Higher Ed (Boston, MA)
- …means to be part of Mass General Brigham. Job SummaryThe Associate Dean of Academic Affairs in the School of Nursing (SON) holds a ranked faculty position at the MGH ... and reports directly to the Dean of the School of Nursing. This senior leadership role provides strategic direction, oversight, and continuous quality improvement of… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Description Job Title: Senior Associate, Clinical Research Supervisor/Manager Title: Senior Manager, Clinical Affairs Job Description Summary: The Senior ... Clinical Research Associate will report to the Associate Director , Clinical Programs, and will play a key role...of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Category Sales Description Job Title : Manager, Customer Service Supervisor/Manager Title: Senior Director of Global Commercial Operations and Strategy Job ... in internal and external audits. Cross-Functional Collaboration Collaborate closely with Sales, Regulatory Affairs , Logistics, Finance, and Supply Chain to align… more
- Ascendis Pharma (Princeton, NJ)
- …As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. This position will ... as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and...without managerial oversight, as appropriate. + Operates independently, with recognition of when to consult departmental senior … more
- Vistra (Cleveland, OH)
- …that are currently available and apply online. **Job Summary** The Director , Regulatory Affairs is a senior leadership role responsible for overseeing ... upgrades, or decommissioning. + Lead, mentor, and develop a team of regulatory affairs professionals, fostering a culture of accountability, compliance, and… more
- Sumitomo Pharma (Tallahassee, FL)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...Comfortable presenting to all levels of the organization including Senior Management. + High degree of organizational awareness, ability… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …to learn, grow and become your best self. Become a **maker of possible** with us. The Sr . Director , Regulatory Affairs is the ranking Regulatory ... with RA business partners, provides input into the budget process for Regulatory Affairs + Represents the Platform in interactions/negotiations with global… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... is responsible to communicate these updates to the identified Sr . Management on a timely basis including R&D for...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
