- Eisai, Inc (Nutley, NJ)
- …also consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is ... your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets...broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...the product lifecycle.?? + Lead development and execution of global product and project regulatory strategy(ies) by… more
- Merck & Co. (Rahway, NJ)
- …required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The ... implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for electronic submissions… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Merck & Co. (Rahway, NJ)
- …Skills: 10 years of experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs , medical and scientific ... Job DescriptionThe Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Merck & Co. (Rahway, NJ)
- …of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... and Development Division, Value & Implementation Human Health, Manufacturing Division, IT Global Medical Proficiency and External Affairs (GMPEA) Global … more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as ... Affairs and may serve as Regional Regulatory Lead or Global Regulatory ...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... post-approval work. Form 2252 for Annual Reports. + Provide support/ RA strategy needed to achieve timely approvals with the...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- Merck (Rahway, NJ)
- … Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) The Associate Director of Regulatory ... implement user requirements, workflows, and metadata standards. + Ensure compliance with global regulatory standards and internal SOPs for electronic submissions… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Merck (Rahway, NJ)
- …years of experience in global patient advocacy and engagement activities + US/ global experience in regulatory affairs , medical and scientific affairs ... **Job Description** The Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Pentax Medical (Montvale, NJ)
- …manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Director , Global ... Time Off and Holiday policy. Want More INFO? The Director , Global Compliance will be a...the PENTAX Medical organization (legal, HR, operations, internal audit, QA/ RA , sales and marketing) with primary focus on the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Partnerships: Actively participate in operational optimization activities by collaborating with Regulatory Affairs , Global Patient Safety, Development ... Global Patient Safety Organization is looking for a Director , PV Enablement to join the team!! **In this...liaison between the PV department and other functions, including Regulatory Affairs , Development Quality, and Regeneron. +… more
- Bristol Myers Squibb (Madison, NJ)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... executed in strict adherence to applicable regulations and BMS standards. The Executive Director leads a team dedicated to maintaining global compliance across… more
