Regional Regulatory Manager

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

49d•$103,900 - $155,900•Onsite

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. This role involves representing and providing input for the respective region at the GRST, leading or supporting the regional regulatory sub-team, and driving regulatory submissions. The manager will ensure optimal planning and execution for both development and maintenance submissions, in alignment with cross-functional teams, to ensure ongoing compliance. This role may also act as a direct contact to local Health Authorities (HAs), such as the FDA, and lead direct interactions with them. The position contributes to the global regulatory strategy with local/regional strategy for assigned projects and involves matrix leadership of the respective Regional Regulatory sub-team. Participation in cross-functional and GRA initiatives is also expected.

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
Demontrated successful interactions with FDA related to strategy and execution of development and maintenance activities.
Demonstrated matrix leadership skill.

Responsibilities

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.