- Sanofi Group (Cambridge, MA)
- **Job Title:** Regulatory Submission lead **Location:** Morristown, NJ/ Cambridge MA **About the Job** Are you ready to shape the future of medicine? The ... be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning,...is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at… more
- Chiesi (Boston, MA)
- …. + Manage and oversee the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling. + Risk ... Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and...labeling and communicate requirements to others as needed. + Lead the development and implementation of Chiesi Global Rare… more
- Takeda Pharmaceuticals (Boston, MA)
- …influence in or leads departmental and cross-functional task-forces and initiatives. + Lead regulatory reviewer in due diligence for licensing opportunities. + ... and business needs and anticipates such changes to lead adaptations to regulatory strategy. + Ensures...reports or other staff responsible. The Senior Director will lead all submission types. + Direct point… more
- Sanofi Group (Cambridge, MA)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... as well as for lifecycle management of products. + May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... and complete work while driving to designated timelines for the execution of submission plans, regulatory requirements and business objectives. + Demonstrates a… more
- Bausch + Lomb (Boston, MA)
- … Regulatory Affairs + Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval + ... the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for...knowledge-sharing initiatives. + Mentor and coach team members in regulatory strategy and submission excellence. + Monitor… more
- Merck (Boston, MA)
- …product life cycle. + Oversee and independently lead the preparation, submission , and follow-up of regulatory applications and ensure quality and compliance ... International Regulatory Affairs with prior experience as a Global Regulatory Lead + Demonstrated scientific knowledge, writing ability, effective… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more
- Sanofi Group (Cambridge, MA)
- …able to manage multiple priorities in parallel. + Strong understanding of regulatory submission processes and health authority interactions. **EXPERIENCES** + ... to support future labeling claims. + Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and… more
- Sumitomo Pharma (Boston, MA)
- …junior staff Phases I-IV Research & Development Activities + As a Regional Regulatory Lead , manage regional (United States and/or European) regulatory ... (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory ...prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission +… more
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