- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ or Cambridge, MA **About the job:** Our team is involved in developing regulatory ... you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable… more
- Bristol Myers Squibb (Madison, NJ)
- …Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead regulatory dossier ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Sanofi Group (Bridgewater, NJ)
- …what you thought was possible. Ready to get started? **Main responsibilities:** + As the Global Regulatory Affairs CMC Lead for Influenza, you will be ... of the regulatory aspects of influenza team. + Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed… more
- Sanofi Group (Bridgewater, NJ)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL) , the Regulatory Strategist (RS) leverages ... on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Merck (Rahway, NJ)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead , is responsible for development and ... final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory … more
- Merck (Rahway, NJ)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's… more
- Insight Global (Raritan, NJ)
- Job Description Insight Global is seeking a Global Regulatory Labeling Product Lead to join a large Pharmaceutical client. This role will support Pharma ... products specifically in the Global Labeling department. Key responsibilities include developing target labeling, managing updates to Company Core Data Sheets… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise ... to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Regulatory Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. ... illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to cross-functional project teams responsible for… more
- Bausch Health (Bridgewater, NJ)
- …CAPAs. **KEY ACTIVITIES/** **RESPONSIBILITIES:** + Serve as a leadership team member for Global Regulatory Affairs + Lead and grow individuals on ... and impact. **OBJECTIVES/** **PURPOSE OF JOB:** The Senior Director of Global Regulatory Operations is responsible for directing and managing the Regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine is recruiting for Associate Director, North America Regulatory Lead in Global Regulatory Affairs, supporting ... of regulatory strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory Team (GRT) and may… more
- J&J Family of Companies (Raritan, NJ)
- …plan, risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including ... leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of… more
- Merck (Rahway, NJ)
- … Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. ... business process management and continuous improvement. + Establish and lead assigned domain Global Process Control Boards...+ Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that… more
- Merck (Rahway, NJ)
- **Job Description** The GRACS Global Process Model Lead is primarily accountable and responsible for the overall governance and leadership of the GRACS Global ... GRACS Global Process Leads, leadership for the Global Process Lead Network, as well as... Model. Champions continuous improvement to meet the evolving regulatory environment. + Provides overall leadership for the GRACS… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross...and presents to senior leadership as required. + Develops, lead , and communicate a business plan to and implements… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …practical aspects of global change management. **Position Responsibilities** + Represent regulatory CMC on and/or lead matrix teams for small molecule ... role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …global trade compliance programs and policies + Monitor and analyze legal and regulatory changes in global trade laws and regulations and advise the Company's ... **Job Description Summary** The Senior Counsel, Regulatory Law, will be a member of the...be a US based attorney with significant experience in global trade laws and regulations and will be responsible… more
- Merck (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... and teams as assigned. **Key Accountabilities:** + Directs activities of the General Medicine global regulatory therapeutic area and team leading to global … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible for development and implementation ... portfolio. + Guide and coach GRLs in creating and implementing global regulatory strategy for registration, maintenance and market expansion of products within… more