- 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
- Eisai, Inc (Nutley, NJ)
- …to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. ... difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based… more
- argenx (New York, NY)
- …Accountabilities and Responsibilities: The person in this role is a key member of the global regulatory leadership team and will be working on a late stage asset ... and coordinate across disciplines to ensure timely filings as applicable Articulate global regulatory strategy to Sr. Management Partner across all functions… more
- argenx (New York, NY)
- …Accountabilities and Responsibilities: The Director GRL is a key member of the global regulatory team. This role serves as a close business partner and ... regulatory team, argenx is looking for a Global Regulatory Lead, based in either Belgium,...and coordinate across disciplines to ensure timely filings Oversee regulatory affairs vendors involved in marketing authorization… more
- argenx (New York, NY)
- …Medical Affairs , Market Access, Commercial, Patient Advocacy, Business Development, Legal, Global Patient Safety, and Regulatory to align on the strategy and ... In support of argenx marketed products or those in development, the Senior Director , Real World Evidence (RWE) Scientist, will serve as the product/indication RWE… more
- argenx (New York, NY)
- …organization, including but not limited to Marketing, Marketing Operations, BIS, Medical Affairs , Market Access, Compliance, Legal and Regulatory Inspire and ... decisions Navigate the Promotional Material Review process by working closely with Legal, Regulatory , and Medical Affairs to prioritize projects and ensure the… more
- argenx (New York, NY)
- …critical role in ensuring scientific accuracy and cross-functional collaboration across Medical Affairs , Marketing, Legal, and Regulatory teams. The role also ... our people, because when we do, we deliver more for patients. The Associate Director , US Medical Review will be responsible for overseeing the medical review of… more
- argenx (New York, NY)
- …people, because when we do, we deliver more for patients. The Associate Director , Professional Relations & Independent Medical Education (PRIME) argenx will play a ... ensuring alignment with therapeutic area imperatives and compliance with regulatory standards. Key Responsibilities: Professional Relations: Support the development… 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
- 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
- Organon & Co. (Jersey City, NJ)
- …Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research. Core elements enabling ... priorities. Developing and implementing patient-centered endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… 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
- 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
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Director , Regulatory Affairs , Molecular Imaging** Join Bayer's Radiology Business ... technology and strategic regulatory leadership. As the Director of Regulatory Affairs , you...+ Compliance & Policy Contribution: Actively contribute to shaping global regulatory compliance policies and procedures that… 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
