Associate Director, Global Regulatory Affairs

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

2d•$135,300 - $202,900•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 company is seeking curious minds that see themselves imagining the unimaginable, working with science and technology to enrich people's lives in Healthcare, Life Science, and Electronics. The Healthcare purpose is to help create, improve and prolong lives by developing medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. The Healthcare team works together across 6 continents with passion and relentless curiosity to help patients at every stage of life. Joining the Healthcare team means becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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.