Associate Director, Global Regulatory Affairs

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 135,000 - 203,000; Full time

Benefits offered by this job

Hybrid work model

Onsite in Billerica, MA

Job summary

EMD Serono, Inc. in Massachusetts seeks an Associate Director, Global Regulatory Affairs Lead to own regional regulatory strategy and execution. This onsite role offers hybrid flexibility with a Tuesday–Thursday onsite presence.

The ideal candidate will lead a regional regulatory sub-team, drive submissions, and coordinate with cross-functional partners while engaging with FDA/EMA and global regulatory strategy.

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 leadership.
• 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.

Skills

Regulatory strategy

Matrix leadership

English proficiency

Education

Advanced degree (US regulatory focus)

Job description

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.

Scope

The Associate Director, Global Regulatory Affairs 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 offering a hybrid flexible work arrangement requiring and onsite presence Tuesday-Thursday with Monday and Friday offered as remote flexible.

Pay Range for this position: $135,300 - $202,900

The offer range represent 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 and education and other job related factors ! ! ! ! 0 0 .. This is time time ? At different … Today's Also??!! ?? ..??！！ ne prou? ??....preec1 --?? !! sghr & ??? ...??”︎ ..… etc…???

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!