Associate Director, Global Regulatory Affairs

Merck•Billerica, MA

1d•Hybrid

About The Position

The Associate Director, Global Regulatory Affairs Lead is responsible for the regulatory strategy and execution for their assigned projects in their region / country. The role involves representing the region at the Global Regulatory Strategy Team (GRST), potentially providing direct input to the Global Project Team (GPT) if the Global Regulatory Lead (GRL) is not in that region, and leading the respective regional regulatory sub-team. The position drives regulatory submissions within their region, ensuring optimal planning and execution for both development and maintenance submissions to maintain ongoing compliance. This role partners with Regulatory Project Management and Submission Management, and may act as a direct contact to a local Health Authority (HA) such as the FDA or EMA, leading direct interactions in such cases. The Associate Director contributes to the global regulatory strategy by developing local/regional strategies for assigned projects and provides matrix leadership to the respective Regional Regulatory Strategy Team (ST). Participation in cross-functional and Global Regulatory Affairs (GRA) initiatives is also expected.

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.