- Aequor (Washington, DC)
- …MS, Pharm D, MD, PhD or equivalent preferred Minimum 3 years in Regulatory Affairs Established regulatory experience Effective collaboration Familiarity and ... regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 accomplish… more
- Eisai, Inc (Nutley, NJ)
- …the digital competencies and strategy within Scientific Communications and Medical Affairs . Lead digital initiatives ensuring successful evaluation, execution and ... communication and presentation skills with a strong scientific background and pharmaceutical knowledge and experience with Medical Affairs systems.Strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience including 5 years ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… 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 collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide ... and attend device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...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)
- …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 ... indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… 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, ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders… more
- Aequor (Thousand Oaks, CA)
- …documents, following applicable standard operating procedures With limited supervision, lead regulatory writing activities for complex product submissions, ... supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA considered ... within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead Dossier planning team meetings for major complex… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and ... including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of… more
- Eisai, Inc (Nutley, NJ)
- …of products. Requirements MD with 2-3 years' experience in oncology within the pharmaceutical industry including 2 years in-house Medical Affairs role or PhD ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Lundbeck (MA)
- …United States in close proximity to a major airportPOSITION SUMMARY:The Field Medical Lead - Neurology (East) will lead , coach, train, and provide direction ... defined medical strategies and tactics across assigned products. This role will lead either general MSL training or Field Medical insight generation, distillation,… more
- Catalent (San Diego, CA)
- …, food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Novo Nordisk Inc. (Chicago, IL)
- 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 collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare...and follow up Must have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a delegate for Executive Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of ... NNI Patient Safety for marketed products. Serves as the lead of the Case Processing Group. Provides support and...twelve years of experience is required, related to Scientific, Regulatory , Pharmaceutical and Medical areas, with at… more
