Sr Dir Regulatory Affairs
The Senior Director Regulatory Affairs will provide leadership on global clinical regulatory activities for the assigned products. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as regulatory leadership on the project teams in this area. 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.
- 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 experience, at least 10 years of hands-on regulatory affairs and successful IND and BLA/NDA submission experience or other relevant drug development experience.
- Must have previous experience with inflammatory/immune mediated diseases; a background relevant to assigned products.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.