Senior Manager Regulatory Intelligence

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 crossfunctional teams to translate regulatory developments into clear actionable insight that supports drug development regulatory strategy and GxP compliance across the organization.

• 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 adhoc requests.
• Identifying businesscritical regulatory changes and proactively communicating implications to crossfunctional stakeholders.
• Supporting regulatory commenting activities including review and drafting of submissions to health authorities and industry organizations.
• Facilitating regulatory intelligence briefings meetings and knowledgesharing sessions.
• Maintaining regulatory intelligence content and contributing to improvements in how intelligence is captured and shared.
• Mentoring junior team members as needed.

• Enjoy staying ahead of regulatory change and applying it in a practical businessfocused 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 crossfunctionally 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.

• 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 are committed to building a workplace with an inclusive culture. 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 sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: annual bonuses or other incentive plans equity awards pension or retirement benefits 401(k) company match health and wellness programs fitness centers insurance benefits (e.g. medical dental vision life and disability) paid time off and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)