- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory Project ... (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... unmet medical needs in North American markets. In the United States , MTPA launched rare diseases treatments...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Merck (Rahway, NJ)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices...in certain states and cities within the United States . Final determinations with respect to… 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 ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Bristol Myers Squibb (Madison, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...which the hired candidate will be working in the US , the salary ranges provided are shown in accordance… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- NJEDA (Newark, NJ)
- …Staff, Managing Director - Policy, Research, and Government Affairs , and Director - Legislative & Regulatory Affairs to develop positions and ... contributes to bill comments prepared by the Legislative & Regulatory Affairs team on proposed legislation that...Selected candidates must be authorized to work in the United States per the Department of Homeland… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety, and Development… more
- City of New York (New York, NY)
- …Mayor's Office of Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the multidisciplinary External Affairs ... Director of OCMH and will directly manage 4 staff members.The Deputy Executive Director , External Affairs will work closely with the Executive Director … more
- Bristol Myers Squibb (Madison, NJ)
- …pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . The Medical Director , US Medical, Multiple Myeloma ... will report to the Senior Director , US Medical Multiple Myeloma Lead. He/she...Responsibilities** + Strategic and Tactical Planning: Responsible for the US Medical Affairs plans, in coordination with… more
- AbbVie (Florham Park, NJ)
- …our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation… more
- AbbVie (Florham Park, NJ)
- …our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more