Senior Director, Regulatory Affairs

The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on clinical regulatory issues and filings but could include CMC issues. With regard to these matters, the Senior Director will provide strategic as well as regulatory leadership on the project teams. Regeneron has a hands-on culture so responsibilities will include direct support to some on-going clinical study activities. The candidate will also contribute, lead and/or supervise IND/CTA and BLA submissions activities.

In this role, a typical day might include the following:

• Provide interpretation of regulatory authorities feedback, policies and guidelines.

• Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Lead the preparation of major clinical submissions required for regulatory approval and, when requested, provide input on CMC submissions.

• Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.

• Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.

• Effectively plan, organize, supervise and/or conduct regulatory activities in close collaboration with leads from other functional areas. Assure compliance with regulations and with project team timelines and milestones.

• Provide organizational support and manage personnel.

• Demonstrated excellence in regulatory liaison/strategy

• Excellent verbal and written communication skills

• Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams

• Ability to thrive in a fast-paced, entrepreneurial environment with high performing colleagues

• Proactive approach to problem solving

• Ability to build strong relationships with co-workers of various backgrounds and expertise

• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

• Flexibility and Integrity

This role might be for you if:

• Doctor of Medicine or a Doctorate in a related Life Sciences discipline.

• Balance strategic thinking and strong analytical skills with ability to execute.

• Big picture focused yet able to master the details.

• Experience with US and international regulatory submissions and an understanding of worldwide large molecule guidelines and regulations.

• Must have at least 14 years of biopharmaceutical or health authority experience or other relevant drug development experience.

• Must have a background relevant to assigned products.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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)

$238,400.00 - $397,300.00