- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be ... Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… 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)
- …Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research. Focusing on Dermatology, ... priorities. Developing and implementing patient-centred endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role is… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… 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 Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...address highest unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs … more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be...Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports… more
- J&J Family of Companies (Raritan, NJ)
- …be considered on a case-by-case basis and if approved by the Company. The Medical Director , Global Medical Affairs , known also as the Study Responsible ... for the medical and scientific oversight of assigned clinical studies within the Global Medical Affairs function. This role ensures the integrity of study… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs (RA) Business Operations believe talented people deserve ... development life cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg, NDAs, MAAs). +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …development, meet regulatory requirements, and support appropriate product use. The Director of Medical Affairs needs to have experience in understanding the ... of possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the...directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs… more
- The Estee Lauder Companies (New York, NY)
- …Companies maintains its position as the leader in prestige beauty. Position Description The Director , Global Public Affairs will partner with the Executive ... Director , Global Public Affairs to develop and execute...Provide subject matter expertise to internal colleagues in legal, regulatory , communications, citizenship & sustainability, supply chain and R&D.… more
- Colgate-Palmolive (New York, NY)
- …to provide solutions that address a wide range of oral health needs. The Director of Scientific Affairs for Colgate Oral Pharmaceuticals is a pivotal role ... York, New York, United States **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …culture of innovation and efficiency. + Liaise and partner closely with head of Global Medical Affairs digital analytics to align key US digital strategy ... Gilead and help create possible, together. **Job Description** The ** Director , USMA Digital Strategy** will play a critical role...role in the developing and executing the US Medical Affairs digital strategy. The individual will lead the vision,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs , Market Sciences, Clinical Development, Legal, Ethics and Compliance, Regulatory , Market Access, Commercial, and Government Affairs & Policy to ... US Oncology Patient oncology advocacy strategy that aligns with Public Affairs , the Oncology Franchise, and corporate objectives, including Commercial and Medical… more
