- 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
- Merck & Co. (Rahway, NJ)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… 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
- 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)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Director , Media Relations & Issues Management is accountable for establishing and leading Novo ... to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director , Media & Stakeholder Relations, and interacts with senior leaders… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
- Danaher Corporation (Port Washington, NY)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director . The Manager ... a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs , Advertising & Promotion Director . + Creatively contribute… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director . The Senior ... typical day might include:** + Management of US and Global (if applicable) regulatory activities associated with...advertising and promotion perspective with minimal guidance from the Regulatory Affairs , Advertising & Promotion Director… more
