- 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...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… 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
- 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
- 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
- Bayer (Whippany, NJ)
- …guidance and category knowledge to US Medical Strategy, Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical ... to make a real difference, there's only one choice.** ** Director Medical Affairs US Radiology...to verify identity and eligibility to work in the United States and to complete the required… more
- Bristol Myers Squibb (Madison, NJ)
- …their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . The Associate Director , US Medical, Multiple Myeloma ... will report to the Director , US Medical Multiple Myeloma Asset Lead. He/she will be...**Key Responsibilities** + Support development and execution of 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
- AbbVie (Florham Park, NJ)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and… more
- Bausch Health (Bridgewater, NJ)
- …international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek ... embody these values, come join our company and help us shape the future. We are all in it...drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you… more
- J&J Family of Companies (Raritan, NJ)
- … strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy, commercial and market access strategy, and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …supported to learn, grow and become your best self. Become a **maker** **of possible** with us . As the Medical Affairs Director of Innovation you will be ... It takes the imagination and passion of all of us -from design and engineering to the manufacturing and marketing...responsible for leading efforts related to Medical Affairs innovation. You will be a member of a… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...NJ - Franklin Lakes **Additional Locations** **Work Shift** NA ( United States of America) Becton, Dickinson and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Primary Work Location** USA NJ - Franklin Lakes **Additional Locations** **Work Shift** NA ( United States of America) Becton, Dickinson and Company is an Equal ... your best self. Become a **maker** **of possible** with us . The Director , Clinical Operations is responsible...direction for clinical execution of projects in support of regulatory approval. This individual is a subject-matter expert in… more