- Eisai, Inc (Nutley, NJ)
- …plus 2 years of experience with Document Management Systems in job offered or as Senior / Regulatory Affairs Associate /Officer. Also requires 2 years of ... to compliance. REQUIRES Bachelor's degree (or foreign equivalent) in Pharmacy, Pharmacology, Drug Regulatory Affairs , or closely related life science discipline… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Astellas (Westborough, MA)
- …Associate II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager CMC ... Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory Affairs , Gene Therapy Developing innovative therapies is one of the most… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director, Global Medical Affairs will provide medical leadership for medical ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… 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 ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Eisai, Inc (Nutley, NJ)
- …be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other ... medical matters relating to assigned products, including promotional and medical affairs materials, labeling, sales training and media/digital materials. Works to… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
- Invenergy (Denver, CO)
- …We own. We operate. We are Invenergy. Job Description Responsibilities + Collaborate with Regulatory Affairs team members in the West region and across regions, ... as well as other internal departments. + Manage external counsel and consultants. + Build relationships with and lobby external stakeholders including those with leadership positions in CAISO, WECC, FERC, state and regional trade organizations,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …high regard for our employees. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory ... reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant… more
- University of Washington (Seattle, WA)
- …natural beauty. **UW Medicine has an outstanding opportunity for a Director of Clinical Regulatory Affairs and Associate General Counsel to join their ... team.** **GENERAL DESCRIPTION AND PURPOSE** The Director of Clinical Regulatory Affairs (Director), Associate General...of Washington, Senior Director of Business & Regulatory Affairs , UW Medicine, General Counsel for… more
- Boehringer Ingelheim (St. Joseph, MO)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director, Regulatory Affairs Pharma Safety & Efficacy ... you will: Act as Regulatory Affairs (RA) team member in projects...Profile and Quality Target Profile. + Works with more senior RA team members to provide consistent regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US ... strategic regulatory guidance to facilitate efficient and compliant drug development...Administration + Provide analysis, advice, and guidance on US regulatory strategies. + Provide expertise on regulatory … more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... changes to Corporate Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership. **About you: To be successful in this… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Associate Director Regulatory Affairs ** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is...internal stakeholders. + Consults with and provides advice to senior management of the Company on strategies and plans… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - ... with Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation and guidance. +… more
- BeiGene (Emeryville, CA)
- The Associate Director, Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development ... corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend...candidates will have experience working as a lead in Regulatory Affairs across two or more major… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Strategic Global Labeling, combines ... with business needs. + Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee… more