The Senior Director of Regulatory Intelligence will lead global regulatory intelligence activities and partner with other members of the Regulatory Intelligence Leadership Team to deliver a robust Regulatory Intelligence program. The responsibility of the Senior Director will primarily focus on providing direction, supervision, and mentorship to the Regulatory Intelligence sub-team that supports Industrial Operations and Product Supply (IOPS) and other strategic functions.
A day in the life may look like:
- Lead and manage a regulatory intelligence sub-team(s) that supports specialized areas within the business
- Serve as a senior resource and advisor on regulatory requirements and changes that impact stakeholders
- Lead, develop, and mentor staff that are monitoring and communicating new, revised, or emerging regulatory requirements from a global to local level
- Oversee the delivery of succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations and potential impact to business policies, process, and strategies
- Ensure timely delivery of regulatory intelligence information to stakeholders to enable them to make decisions, refine strategies, and manage potential compliance risks
This may be the right role for you if you have:
- Lead cross-functional teams in the understanding of regulatory changes and identify opportunities for providing feedback on proposed regulations, rules, and guidance
- Support business stakeholders in driving strategies for compliance with global regulatory requirements
- Oversee the review of regulatory information as it relates to the business and stakeholder requests
- Develop recommendations to draft rules and guidance documents by Health Authorities regarding how they should be written or revised in collaboration with internal stakeholders
- Liaise with Legal and Public Policy and Government Affairs (PP&GA), as necessary, to ensure consistency in interpretation and communication of regulatory information
In Order to be considered qualified for this role you must have:
- Must have a Bachelor's degree with 12 years of relevant biopharmaceutical experience, at least 8 years of hands-on regulatory affairs or regulatory intelligence experience.
- Balance of strategic thinking and strong analytical skills with ability to execute.
- Understanding of worldwide regulatory agencies, regulatory submissions and regulations.
- Understanding of available tools for identifying, cataloging and responding to regulatory publications on matters related to Regeneron.
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.
Salary Range (annually)
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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