Regional Regulatory Manager
About this opportunity
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.
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 sub team.
Participate in cross-functional and GRA initiatives.
Required Background
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 and onsite presence at least 3 days per week.
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!
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 151 comparable Manager Regulatory Affairs roles across 47 biopharma companies.
Salary context
45 of 151 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 151 comparable roles
+ 19 more countries
Seniority mix
151 of 151 peers have a known seniority level
Therapeutic area mix
23 of 151 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Open in 4 locations
Open in 4 locations
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.