Regional Regulatory Manager

EMD Serono, Inc.; Billerica (MA); On-site; USD 103,900 - 155,900; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Job summary

EMD Serono, Inc. is seeking a Regional Regulatory Manager in Billerica, MA to oversee the regulatory strategy for projects. The position involves collaboration with cross-functional teams and direct communication with local health authorities such as the FDA.

Candidates should possess an advanced degree and regulatory affairs experience in drug development in the US. The role ensures compliance with regulatory submissions and offers a competitive compensation range of $103,900 - $155,900, along with comprehensive benefits.

Qualifications

• At least 1 year of regulatory affairs experience in drug development in the US.
• Demonstrated successful interactions with FDA related to strategy and execution.
• Demonstrated matrix leadership skill.

Responsibilities

• Represent and provide input for your respective region at the GRST.
• Drive the regulatory submission in your region ensuring compliance and optimal planning.
• Lead the direct interactions with local health authorities like the FDA.

Skills

Regulatory affairs strategy experience

Matrix leadership

Successful interactions with FDA

Education

Advanced degree (e.g., PhD, PharmD, MD)

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

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.

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.

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.

Qualifications

• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 1 year 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.
• Demonstrated matrix leadership skill.

Location

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

Compensation

Pay Range for this position: $103,900 - $155,900. 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!