- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partner side) _CDx RA Policy and Intelligence_ : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... + Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination… more
- J&J Family of Companies (Raritan, NJ)
- …of America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in **Raritan, ... with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health… more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... Join our global diversified pharmaceutical company enriching lives through our...assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... Join our global diversified pharmaceutical company enriching lives through our...regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle… 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 ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… 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 ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational...area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs … more
- AbbVie (Florham Park, NJ)
- … Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory , HEOR and other functional areas, provides leadership, oversight, and support ... title will be based on qualifications listed below. Purpose: The Senior Director provides specialist medical and scientific strategic and operational input into core… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... + Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + Createahighperformingteamenvironmentandacohesiveculturedrivenbyvaluesof… more
- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (50% hybrid) Type: 12-month contract Must haves: + Must be local for hybrid ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Director , Corporate Affairs , Oncology Commercialization Communications will drive ... strategically and execute tactically. The position will report to the Executive Director , Global Oncology & Cell Therapy Commercialization Communications and… more
- Scotiabank (New York, NY)
- Associate Director , Legal Counsel, Legal and Corporate Affairs **Requisition ID:** 206757 **Salary Range:** 180,000.00 - 224,700.00 _Please note that the Salary ... committed to results, in an inclusive and high-performing culture. ** Global Banking and Markets** Global Banking and...front office and other internal stakeholders on legal and regulatory matters related to the business. + Independently draft… more
- Sanofi Group (Morristown, NJ)
- …the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Sanofi Group (Morristown, NJ)
- …Market + Track record of successful cross-functional collaboration + Familiarity with global regulatory environments and requirements + Experience in lifecycle ... **Job title** **_:_** Global Medical Senior Director Dermatology and...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Sr. Director , Data Quality and Integrity ( Global R&D & PV QA) ensures ... solutions, integrates AI technologies, and drives process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans,… more