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Senior Manager Regulatory Intelligence

Job Description

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We are seeking a Senior Manager, Regulatory Intelligence to play a key role in monitoring, interpreting, and communicating changes in the global regulatory landscape, with a strong focus on EU regulatory strategy and pharmacovigilance.

In this role, we partner closely with cross‑functional teams to translate regulatory developments into clear, actionable insight that supports drug development, regulatory strategy, and GxP compliance across the organization.

A Typical Day May Include

  • Monitoring and assessing new and emerging regulatory guidance, legislation, and policy from global health authorities and industry bodies.
  • Evaluating regulatory developments to determine relevance and impact on development programs, regulatory strategy, and internal processes.
  • Preparing concise regulatory intelligence summaries, reports, and presentations tailored to different stakeholder groups.
  • Acting as a point of contact for regulatory intelligence questions and ad‑hoc requests.
  • Identifying business‑critical regulatory changes and proactively communicating implications to cross‑functional stakeholders.
  • Supporting regulatory commenting activities, including review and drafting of submissions to health authorities and industry organizations.
  • Facilitating regulatory intelligence briefings, meetings, and knowledge‑sharing sessions.
  • Maintaining regulatory intelligence content and contributing to improvements in how intelligence is captured and shared.
  • Mentoring junior team members, as needed.

This Role May Be For You If You

  • Enjoy staying ahead of regulatory change and applying it in a practical, business‑focused way.
  • Have strong experience in regulatory affairs and/or pharmacovigilance within pharma or biotech.
  • Are confident interpreting regulatory guidance and understanding its impact across the drug development lifecycle.
  • Are comfortable working cross‑functionally and engaging with a range of stakeholders.
  • Can work independently, manage competing priorities, and deliver to deadlines.
  • Value clarity, accuracy, and quality in your work.
  • Are motivated to improve processes and contribute to how regulatory intelligence is delivered across the organization.

What You’ll Bring

  • 8+ years’ experience in the pharmaceutical or biotech industry, or within a health authority, with a focus on Regulatory Affairs and/or Pharmacovigilance.
  • Strong understanding of EU and US regulatory and pharmacovigilance requirements across the drug development lifecycle.
  • Experience sourcing, monitoring, and interpreting regulatory information from health authority platforms and other intelligence sources.
  • Strong analytical skills, with the ability to identify key regulatory risks and implications.
  • Clear, concise written and verbal communication skills.
  • Strong organizational skills and attention to detail.
  • A collaborative, practical approach to working across teams and functions.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.