- Aequor (San Diego, CA)
- US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: He/She will be responsible for representing regulatory function to approve promotional material ... preferred Regulatory Certification (RAC) preferred Minimum 5 years in Regulatory Affairs , including leadership roles Experience: Experience in promotional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... solutions to the world.Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for ... research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Aequor (Newbury Park, CA)
- … affairs processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Aequor (Newbury Park, CA)
- …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training materials and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and attend device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company ... 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)
- …Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory... lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states … 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Reg Policy Lead , responsible for tactically coordinating engagement with US regulatory bodies and trade associations, incl. PhRMA. Qualifications: Successful ... working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define...regulatory changesIn the short term, act as the US Reg Intel lead , responsible for collecting,… 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, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… 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 ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...us ? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an… more
- Piper Companies (Philadelphia, PA)
- …with over three years of pharmaceutical/biotech industry experience, including two years in regulatory affairs or operations.. Proven track record in supporting ... and develop content plans for IND & CTA dossiers.. Lead interactions with external publishing teams to compile IND...submission requirements and familiarity with cell and gene therapy regulatory standards in major markets like the US… more
- Lundbeck (MA)
- … us on our journey of growth!This position will cover the Eastern half of the United States .Candidates may live in any state within the Eastern United ... States in close proximity to a major airportPOSITION SUMMARY:The Field Medical Lead - Neurology (East) will lead , coach, train, and provide direction to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... experiment with us ? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position The therapeutic area Operations Lead… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This… more
