- Aequor (Thousand Oaks, CA)
- …license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research , Development or related area 5&plusyears ... FULLY REMOTE Regulatory Writing Senior Manager ln this vital role...responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop ... and maintain positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
- Eisai, Inc (Nutley, NJ)
- …responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research , medical education, research ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Eisai, Inc (Nutley, NJ)
- …and management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting...The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary Responsible for leading ... and developing global regulatory strategy for assigned... strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Merck & Co. (North Wales, PA)
- …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 correspondence with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role offers ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryLeadership responsibility ... for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology… more
- Merck & Co. (Rahway, NJ)
- …effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, business development & ... execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and market researchSupport… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... Ph.D., MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory … more
- Merck & Co. (Rahway, NJ)
- …and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization ... critical role in driving alignment and execution globally across Regulatory CMC, GRACS, our Research and Development...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Merck & Co. (Rahway, NJ)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs to ... and supervision of the TA-Head or CRD.Requires understanding of local regulatory environment.Scientific and clinical research knowledge is required.Understanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Director, Head… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...A minimum of 6 years relevant experience required; academic research or pharmaceutical development experience preferred Board certification or… more
