- Scismic (Boston, MA)
- …company that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the ... development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. This role will lead US submission work.Your role:You will… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …Administration (FDA) guidance and provides technical guidance within and outside R&D for regulatory and quality matters.The Associate Director / Director , ... Associate Director / Director , Analytical Research...She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and… more
- Merck & Co. (Boston, MA)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, the Executive Director may ... Job DescriptionThe Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director , Quality Technical, is responsible for leading a team that supports deviation management, change control, site ... activities with department objectivesFUNCTIONAL EXPERTISE:Specific to Technical Support, the Associate Director will be responsible for comprehensive management… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …advanced degree preferred.At least 8+ years of regulatory affairs experience for the associate director or 10+ years of Regulatory affairs experience for ... The position is responsible for supporting and leading activities within Regulatory Affairs department, to support clinical development of oncology products at ORIC.… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …range for director level candidates is between $200,000-$235,000 and associate director level candidates is between $160,000-$180,000. The final salary ... important to us as an organization.The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... team, reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and maintain the strategic planning digital… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (North Wales, PA)
- …Pulmonary Arterial Hypertension (PAH)/Rare Disease Business Unit is recruiting an Associate Director of Healthcare Consumer (HCC) Marketing for PAH ... in the United States.- The Associate Director of HCC Marketing will lead...rare disease therapy commercialization, -and an understanding of US regulatory environment. Location: This position is location agnostic.-For remote… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Site Services Procurement (NORAM) This Procurement Associate Director role will be a member of ... and spoken).Preferred Experience and Skills:MBA or advanced degree.Understanding of regulatory requirements and industry standards related to site services within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
