Description du poste
We are looking for a leader to guide our CMC & Combination Products regulatory team, supporting a global portfolio of drug and device products with a strong focus on the European Union. In this role, we work closely across functions to shape clear regulatory strategies that support development and keep submissions moving forward. You’ll play a central role in connecting teams, guiding decisions, and ensuring global regulatory alignment.
A Typical Day:
- Leading a team delivering CMC and combination product regulatory activities
- Shaping global regulatory strategies, with focus on EU requirements
- Advising senior leaders on regulatory direction and key considerations
- Overseeing submissions and resolving complex compliance issues
- Working closely with regulators, partners, and external organisations
- Monitoring new regulations and assessing impact on the portfolio
- Improving processes and identifying more efficient ways of working
- Supporting team development through coaching and regular feedback
This Role May Be For You If You:
- Enjoy leading teams and helping others grow in their roles
- Like setting direction while staying close to the detail
- Are comfortable working with senior stakeholders across functions
- Prefer a mix of strategic thinking and hands-on problem solving
- Build strong, steady relationships with external partners and regulators
- Stay organised when handling multiple priorities at once
- Look for practical, simple ways to improve how work gets done
- Value clear, direct communication and keeping people aligned
To be considered, you should bring substantial experience in regulatory affairs with a focus on CMC and/or combination products, including developing and guiding global regulatory strategies. A bachelor’s degree is required (an advanced degree is strongly preferred). You should have experience leading teams, working with senior stakeholders, and a strong understanding of EU regulatory requirements. Experience supporting global submissions is essential.
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.