- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regardless of where they live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and ... lead, manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned...Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within Gilead's ... Global Regulatory Affairs organization and acts as a...Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… more
- AbbVie (Florham Park, NJ)
- …and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Provides input in design ... business strategy . International experience is a plus. Senior Scientific Director Qualifications: + Advanced Degree PhD or PharmD. Additional post doctorate… more
- AbbVie (Florham Park, NJ)
- … activities, generation and dissemination of data supporting the overall scientific strategy . + Responsible from Medical Affairs for the design, analysis, ... *Position title will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational input into… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + ... rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in...preparedness for the respective MA inspections in alignment with regulatory and company strategy . + Act as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improve life by advancing the care of patients with life-threatening diseases. ** Director , Public Affairs , US HIV Prevention Communications & Media Relations** ... This role will work in partnership with the Sr Director in developing public relations strategies and tactics that...colleagues in the US Commercial organization, Clinical Development, Medical Affairs , Legal, and Government Affairs as well… more
- Bayer (Whippany, NJ)
- …Medical Affairs Communications Oncology** The Director , Medical Affairs Communications Oncology manages strategy and implementation surrounding the ... well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance, Regulatory Affairs and Legal Departments; + The incumbent participates… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …you if you:** * Want a highly visible position with frequent interactions with Regulatory Affairs , Clinical, Legal and Commercial. * Have outstanding work ethic ... As an Associate Medical Director of Medical Affairs you will...Affairs you will support the our Ophthalmology medical strategy , planning & execution of these activities. This role… more
- Danaher Corporation (New York, NY)
- …& Scientific Affairs team and report to the lead medical director responsible for innovation, strategy , and evidence development and dissemination. If ... time and within budget. Work closely with internal teams such as clinical research, regulatory affairs , marketing, and sales to integrate medical affairs … more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job title** : Global Medical Director , Evidence Generation - Insights and Strategy...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Bayer (Whippany, NJ)
- … Leader-IVD** The Senior Director , Global Regulatory Leader-IVD acts as a regulatory strategy lead primarily for Cell & Gene Therapy (CGT) but also for ... with diagnostic co-development partners and leads the development of diagnostic regulatory strategy in multiple projects in clinical development and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned products or projects. You ... ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents… more
- Bayer (Whippany, NJ)
- …Files, etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with ... **Email:** hrop_###@bayer.com **Job Segment:** Medical Device, Biomedical Engineering, Compliance, Regulatory Affairs , Product Development, Healthcare, Engineering, Legal,… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Reporting to the Sr Director of WW Portfolio Strategy , this individual serves as the BMS ... MS with general knowledge of pharmaceutical operations, ie, advocacy, medical affairs , clinical development, regulatory , commercialization, + Understanding of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned products or projects. You ... or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help...oversee and guide their sub-team participation. + Defines the regulatory strategy for multiple Gilead products or… more
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... lives with diagnostic tools that address the world's biggest health challenges. The Director , Product Portfolio Strategy and Enablement role is responsible for… more