- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop ... maintain positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish… 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 ... 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
- Aequor (Newbury Park, CA)
- …for inclusion in regulatory submissions. Coordination and execution of regulatory affairs processes and deliverables. Works under under the direction ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory ... and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.Essential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Aequor (TX)
- …NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of ... regulatory support, review and approval of applications with the...the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… 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, ... need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence,… 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 ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… 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
- 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 ... diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and… more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… 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 ... development and/or life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health systems strategy to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... Market Access: Work collaboratively with the market access and public affairs function to support market access strategies for diagnostic products Innovation… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. Under… 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 ... strategies, and marketing promotion. Act as a liaison between marketing, medical affairs , and market access. This role will have direct reports supporting TA… more
- Merck & Co. (Rahway, NJ)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside and outside of CMR to ensure… more
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