- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline ... maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a ... part of our Global Regulatory Affairs organization.In this role, you will work in...you will work in close collaboration with the Global Regulatory Lead(s) on a compound in late-stage development to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Merck & Co. (Rahway, NJ)
- …Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You ... will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring...include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products,… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Lower Gwynedd, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... 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. (Bernards, NJ)
- …and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, ... of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may ... breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational work for ... dedicated colleagues while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
