The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, 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. Own 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 partners, in the preparation, review, and completion of documents for regulatory submissions.
* Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines.
* Provide interpersonal support and lead personnel.
* Excellent verbal and written communication skills
* Critical thinking, leadership skills, assertiveness, 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 successful colleagues
* Ability to function at a high level in a team setting whether leading the group or acting individually
This role might be for you if:
Must have at least 14 years of Life Science experience, at least 10 years of hands-on regulatory affairs and successful IND and BLA/NDA submission experience.
Doctor of Medicine or a Doctorate in a related Life Sciences field (PhD, PharmD, MD)
Balance critical thinking and strong analytical skills with ability to implement.
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.
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.
- Clinical Works
- Critical Thinking
- Doctor Of Medicine (Md)