Global Regulatory Lead
About The Position
The Global Regulatory Lead supports the regulatory strategy for bringing new drugs, medical devices, and combination products to market. It involves preparing and managing key submissions like INDs and NDAs while coordinating with internal teams. The position also helps plan and participate in meetings with regulatory agencies such as the FDA. Additionally, it includes reviewing product labeling and advertising to ensure compliance, analyzing regulations, and monitoring competitor approvals. The role works cross-functionally to provide scientific and regulatory input on projects. Overall, it helps ensure products meet all regulatory requirements throughout their lifecycle.
Requirements
- Bachelor's Degree Required
- About 3-5 years of relevant regulatory experience across multiple regulatory classes (NDA, Monograph, Medical Device).
- Good written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.
- Experience in compiling regulatory dossier and executing FDA submission.
Responsibilities
- Provide assistance in developing and implementing the regulatory strategy for new products/claims for different regulatory classes (drug, medical device, combination products).
- Lead the operational execution of regulatory submissions for NDA products working with the electronic document specialists and publishers.
- Prepare IND submission documents aligned with the regulatory strategy and support lifecycle management of the IND.
- Support the planning of meetings with regulatory agencies as appropriate including participation in agency meetings on specific topics.
- Review and approve labeling and advertising for NDA products.
- Review concept review, commenting and approval, competitive challenge research/responses.
- Assist in the analysis and interpretation of government medical device regulations.
- Research competitive product approval status and emerging FDA requirements to support switch programs.
- Support Global Regulatory Affairs initiatives
- Contributes to interdepartmental projects and supports the provision of scientific, and technical information.
- Provide assistance and represent Regulatory Affairs by participating as a team member on approved projects and programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
