- Title: Global Regulatory Team Lead
- Code: RCI-03976
- Location: Bridgewater New Jersey (NJ) 08807
- Posted Date: 04/07/2021
- Duration: 5 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the client Global Business Unit (GBU). He/she is responsible for developing long and short-term regulatory strategies for the projects and products under his/her accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products.
The GRTL will determine regulatory requirements and options for global submissions/approvals and present the regulatory registration strategy to project team in line with the disease prevalence and commercial assessment of target product profile
The GRTL will work transversally to ensure a properly functional regulatory sub-team.
The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
- Lead Global regulatory Team (GRT) by providing project background and updates
- Seek feedback from GRT on regulatory expertise knowledge of each specific area (i.e labelling, regional, publishing etc)
- Plan GRT activities pertaining to project timelines
- Years of Experience: 3 - 6 Years
- Looking for someone with a few years of regulatory experience (3 would be sufficient) with basic regulatory knowledge of EU/US.
- Regulatory experience with projects in development (clinical studies, and documentation related to IND/CTA submissions ).
- Has done contract work in Big Pharma and understand that matrix (transversal collaboration, project teams etc).
- Degree in science (BS/MS).
Adapts quickly, flexible and embraces change, looks for solutions on own with some guidance, positive mindset, multitasking, honest/transparent.