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Corporate Attorney / Government Public Attorney in Tarrytown, NY

Regeneron Pharmaceuticals, Inc. Mar 31,2015 Location USA Tarrytown NY
This job is expired...

In-House

Attorney

Corporate

Government / Public Law

Litigation - Whistleblower - CFTC

Min 8 yrs required

Profile

Director, Corporate Counsel – R&D and Regulatory Law Duties: Provide legal support to a wide range of internal clients, with a particular focus on Regulatory Affairs and Research & Development (R&D). Be responsible for advising the R&D and Regulatory Affairs departments on emerging legal and regulatory issues and providing advice and counsel on a wide range of regulatory issues in the U.S. and overseas. Serve as a proactive, solutions-oriented ethical counselor to internal Regeneron clients. Work with those handling public policy matters for the company and may have responsibility for supporting one or more of products or product candidates. Provides advice and counsel to the Regulatory Affairs department and a variety of internal clients on legal and regulatory matters. Advise the R&D organization on matters related to clinical trials, informed consent, research collaborations etc. Collaborate with the Compliance department in identifying risk areas in the R&D area and developing risk mitigation strategies. Conduct training to different client groups on a variety of legal and regulatory issues. Serves as the Law Department’s representative on the Regulatory Intelligence Steering Committee, advising on emerging regulations, drafting comments on proposed regulations as appropriate, advising business units on measures necessary to comply with new regulations etc. Provide advice and counsel to the Compliance function including monitoring and interpreting new legislation and regulatory/compliance guidance, assisting with internal policy development and training, and participating in corporate compliance monitoring initiatives. Serve as primary product attorney for one or more Regeneron products or product candidates. Review and approve business and marketing initiatives, including consultant meetings, promotional materials and sales initiatives.

Qualification and Experience

Requirements: BA/BS and JD Degree with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. 8+ years legal experience. Healthcare/pharmaceutical and/or biotech experience a plus. Experience with the False Claims Act, Anti-Kickback Statute, privacy laws, GXP regulations etc. a plus. Knowledge of the Food, Drug & Cosmetic Act and implementing regulations as well as other laws and regulations impacting the healthcare industry. Exceptional communication skills, including presentation capabilities, interpersonal skills and conflict resolution. Excellent negotiation skills requiring exceptional interpersonal communication and oral and written communication skills. Ability to persuade with verbal and written communications involving multiple key client groups. Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations. Ability to work independently on projects, set and meet aggressive deadlines, and juggle multiple matters.

Additional info

Requisition Number: 3528BR

Company info