Regional Regulatory Manager
About The Position
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for their assigned projects and for supporting local regulatory activities in their region / country. Represent and provide input for your respective region at the GRST. Lead or support the respective regional regulatory sub-team. Drive the regulatory submission in your respective region. Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management. May act as direct contact to a local HA (e.g. FDA). Lead the direct interactions with the respective local HA in this case. Contribute to the global regulatory strategy with local / regional strategy for assigned projects. Matrix leadership role of respective Regional Regulatory subteam. Participate in cross-functional and GRA initiatives.
Requirements
- Advanced degree (e.g., PhD, PharmD, MD, or equivalent)
- At least 1 year of regulatory affairs strategy experience in drug development in the US
- Demonstrated successful interactions with FDA related to strategy and execution of development and maintenance activities
- Demonstrated matrix leadership skill
Responsibilities
- Execution of the regulatory strategy for assigned projects
- Supporting local regulatory activities in their region / country
- Representing and providing input for their respective region at the GRST
- Leading or supporting the respective regional regulatory sub-team
- Driving the regulatory submission in their respective region
- Ensuring optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance
- Partnering with Regulatory Project Management and Submission Management
- Acting as direct contact to a local HA (e.g. FDA)
- Leading the direct interactions with the respective local HA
- Contributing to the global regulatory strategy with local / regional strategy for assigned projects
- Matrix leadership role of respective Regional Regulatory subteam
- Participating in cross-functional and GRA initiatives
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
- other perquisites
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What This Job Offers
Job Type
Full-time
Career Level
Senior
