Sr Mgr. Regulatory Affairs

We are Regeneron, a leading science-based biopharmaceutical company dedicated to transforming lives through ground-breaking medicines. Our mission is to address high unmet medical needs across a range of therapeutic areas, including ophthalmology, oncology, cardiovascular, allergic, inflammatory, infectious, and rare diseases. As a Senior Manager, Regulatory Affairs (EU), you will play a meaningful role in crafting the future of global healthcare by driving regulatory strategies and ensuring compliance for our innovative development programs in metabolism and ophthalmology.

This is your chance to create a meaningful impact on patients’ lives while collaborating with a team of elite scientists and regulatory professionals.

In a typical day you will:

• Develop and implement regulatory strategies for assigned programs in collaboration with global development teams.
• Lead the preparation and submission of Clinical Trial Applications (CTAs) via the Clinical Trials Information System (CTIS) to multiple EU member states.
• Lead regulatory activities such as CTA amendments, annual reports, and other key submissions.
• Conduct critical analyses of clinical and preclinical data, providing interpretations and conclusions to guide decision-making.
• Review clinical protocols and study reports to ensure alignment with EU regulatory requirements.
• Lead the preparation and execution of EU Scientific Advice requests, including meetings with the European Medicines Agency (EMA) and other national agencies.
• Stay ahead of the curve by monitoring and interpreting new EU Commission and EMA guidelines, and provide training to scientific staff as needed.
• Represent Regeneron in interactions with external stakeholders, including EMA scientific committees, EU national agencies, and industry associations.

This role may be for you if you:

• Thrive on developing and implementing regulatory strategies that drive innovation and compliance.
• Have a proven track record navigating the complexities of EU regulatory requirements, including Clinical Trial Applications and interactions with the EMA.
• Are passionate about advancing groundbreaking treatments in metabolism and ophthalmology.
• Excel in establishing relationships and influencing collaborators across diverse teams.
• Are diligent, with a talent for analyzing data and crafting clear, concise regulatory documents.
• Enjoy collaborating with multidisciplinary teams to solve challenges and achieve shared goals.
• Are proactive in staying informed about emerging regulatory trends and guidelines.

To Be Considered:

You must have a minimum of 4+ years of regulatory experience focused on supporting products through clinical development. An advanced degree in a scientific field is required, and experience with the EMA (e.g., scientific advice, orphan designation, Pediatric Investigation Plans) is highly preferred. A consistent record of supporting EU Clinical Trial Applications through approval and study start-up is crucial.

Preferred qualifications include experience in regulatory strategy for metabolism or ophthalmology programs, as well as marketing authorization applications or lifecycle management of approved products via the centralized procedure. Strong written and verbal communication skills, along with the ability to negotiate and clearly articulate positions to partners, are critical for success in this role.

Join us in shaping the future of medicine while advancing your career in a dynamic, collaborative, and inclusive environment. Together, we can make a difference.

Apply today to be part of our mission to transform lives.

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.