- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on ... Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Bloomberg (New York, NY)
- …Global Exam Management and Regulatory Inquiries Officer, you will work with the Global Regulatory Engagement Lead , the Chief Risk Office and Global ... Bloomberg andits regulated entities and implement lessons learned strategies + Supportthe Global Regulatory Engagement Lead and the Head of Risk and… more
- Sanofi Group (Morristown, NJ)
- …Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The ... team responsibilities include but are not limited to: global regulatory CMC strategies, submission dossiers and approvals, direct contact/liaison with FDA/EMA… more
- Citigroup (New York, NY)
- …management position within the Controllers Organization that will report up through the Global Head of Regulatory and Capital Reporting. The individual will ... support and execute remediation of critical gaps in regulatory reporting and bolster the team's ability to meet regulatory commitments to various constituencies… more
- Sanofi Group (Morristown, NJ)
- … Regulatory Team (GRT) for the Innovation Franchise and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) will ... thought was possible. Ready to get started? **Main Responsibilities:** + Enables the Global Regulatory Lead (GRL) by providing quality regulatory input… more
- Sanofi Group (Morristown, NJ)
- …the Vaccines Global Business Unit (GBU). The position is reporting to the PPH Global Regulatory Lead but may also support other Therapeutic areas based ... on millions of patients around the world. **Main Responsibilities:** + Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and… more
- Sanofi Group (Morristown, NJ)
- …this innovative therapeutic platform. The position is within the mRNA Therapeutic Area, reporting to Global Regulatory Lead . As a key member of the Global ... world. **Main Responsibilities** + The Regulatory Strategist (RS) enables the Global Regulatory Lead (GRL) providing quality regulatory input and… more
- Merck (Rahway, NJ)
- …and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the ... agencies for multiple indications simultaneously + Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory … more
- Bayer (Whippany, NJ)
- … Regulatory Strategist, Cell & Gene Therapy (CGT) Combination Products requires a Global Regulatory Expert who can lead Combination Product Asset ... make a real difference, there's only one choice.** **Director, Global Regulatory Strategist, CGT Combination Products** The...Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams;… 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 ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or Morristown, ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty...Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Affairs Global Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... will serve as a central contact and expert for global Regulatory teams in interpreting content and...advisor to cross-functional partners, stakeholders, and teams. You will lead impact assessments on major global labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Strategy_ _:_ Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... HA meetings as appropriate + In collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence_ : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Bank of America (New York, NY)
- Global Markets Non-Financial Regulatory Reporting (GM NFRR) Operational Monitoring New York, New York;Charlotte, North Carolina **Job Description:** At Bank of ... Enterprise Policies, data sourcing, preparation, governance, and oversight of Global Markets regulatory reports - with the...for a highly talented individual to become Operational Monitoring Lead - to lead & design strategy… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling ... labeling impact, development of alternate proposals, and negotiation strategies. + Lead , represent or contribute on product-specific Regulatory and… 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Citigroup (New York, NY)
- …management position within the Controllers Organization that will report up through the Global Head of Regulatory and Capital Reporting. The individual will ... Provide thought leadership to peers and program leaders on US regulatory changes and lead efforts to implement those changes within the reporting framework.… more