- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under...cycle management of existing products. May serve as the lead regulatory representative on the project team… more
- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC ... manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams and… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Eisai, Inc (Nutley, NJ)
- …quality of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician in global registration trials and manages all related statistical ... responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis… more
- Lundbeck (Bronx, NY)
- …that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than ... in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... action Item follow-upAttends CRO and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management… more
- 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
- 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)
- …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
- American Express (New York, NY)
- …on #TeamAmex. American Express is seeking a skilled Regulatory Compliance Director to lead the global regulatory compliance function within the Global ... on maintaining a comprehensive and up-to-date legal inventory that aligns with global regulatory requirements and supports business objectives. + Design and… more
- Citigroup (New York, NY)
- … Engagement team and report directly to the Capital Markets Regulatory Engagement Lead . Citi's Global Regulatory Engagement Team is responsible for the ... The Capital Markets Regulatory Engagement Officer will be part of Citi's...(ie, Examinations. Continuous Monitoring and Requests for Information) + Lead and/or assist in providing oversight for Capital Markets… more
- Stryker (Mahwah, NJ)
- …workplace flexibility. As the **Senior Manager, Regulatory Affairs** , you will lead and coordinate global regulatory activities including regulatory ... of global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III medical devices +… 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
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead...Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and… more
