Associate Director, Global Regulatory Affairs

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Merck Group seeks an Associate Director, Global Regulatory Affairs to own regional regulatory strategy and execution at the Billerica, MA site onsite three days per week. You will lead the regional regulatory sub-team, drive submissions and ongoing compliance for development and maintenance, and partner with Regulatory Project Management, including direct interactions with regulators such as FDA and EMA when needed. The role informs strategy with a regional view and requires an advanced degree with 5 years in US regulatory affairs, a proven FDA/EMA NDA/BLA track record, and strong matrix leadership. To apply, tailor your resume to highlight regional leadership, successful submissions, cross functional collaboration, onsite readiness, and GRST/GPT collaboration.

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Scope: 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.

Minimum Qualifications

• 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.

Location: This is an onsite role based in our Billerica, MA facility requiring and onsite presence at least 3 days per week.

Pay Range for this position: $135,300 - $202,900. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here: https://careers.emdgroup.com/us/en/benefits 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!