Associate Director, Global Regulatory Affairs

Merck•Billerica, MA

1d•Hybrid

About The Position

The Regional Regulatory Lead is responsible for the regulatory strategy and execution for their assigned projects in their region / country. Responsibilities include, but are not limited to the following: Represent and provide input for your respective region at the GRST. May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region. Lead 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 or EMA). 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 ST. Participate in cross-functional and GRA initiatives.

Requirements

Advanced degree and at least 5 years 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.
Experienced strategist with a record of successful HA interactions with FDA or EMA including NDA / BLA activities.
Demonstrated strong matrix leader.
Excellent spoken and written English.

Responsibilities

Represent and provide input for your respective region at the GRST.
May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region.
Lead 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 or EMA).
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 ST.
Participate in cross-functional and GRA initiatives.