Senior Director, Regulatory Affairs, Neuroscience

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
10417BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Senior Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron's clinical asset candidates.

Responsibilities:
• 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. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
• Responsible for quality and timeliness of IND/CTA and BLA/MAA submissions. Interacts 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.

Education: Ph.D. or Pharm D. Required

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 10417BR