- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to… more
- Aequor (Washington, DC)
- … classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices) Responsibilities: Monitor emerging regulatory policy issues, including ... - 1 PM EST SCOPE OF RESPONSIBILITIES: accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team will be at ease working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you will prepare and coordinate the preparation of regulatory submission documents ... of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy… more
- Merck & Co. (North Wales, PA)
- …review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that ... promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You ... will lead a global regulatory team to develop and execute regulatory ...eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, ... regulatory , and business perspectives to ensure compliance with evolving...regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to ensure accurate and high-quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager, Regulatory Operations will be responsible for functional activities related to US/Ex-US ... regulatory submissions. In addition, this individual will be responsible...Break (typically between Christmas and New Year's Day).ADDITIONAL US BENEFITS: Medical , dental, and vision plansCompany-provided short- and long-term disability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and… more
- Aequor (Thousand Oaks, CA)
- … documents in Regulatory Affairs, Research, Development or related area 5&plusyears of experience in medical writing in the Biotech/Pharmaceutical industry ... FULLY REMOTE Regulatory Writing Senior Manager ln this vital role...work of contract and freelance writers and mentor junior medical writers as assigned Lead departmental and cross-departmental initiatives,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- The University of Vermont Health Network (Burlington, VT)
- JOB DESCRIPTION:Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the ... implementation of the organizations regulatory program to assure that...Registered Nurse (RN) license required. The University of Vermont Medical Center is moving toward an all Bachelor of… more
- Insmed Incorporated (Bridgewater, NJ)
- …issues for assigned products; provides content guidance and functional approval for regulatory responses for other Medical Safety Leads.Maintain and evaluate ... Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the...time and in accordance with all relevant company and regulatory policies and procedures. In addition, the ED will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and… more
