Associate Counsel, Regulatory

Profile

Associate Counsel, Regulatory
Responsibilities: Provide legal-FDA regulatory advice to Medical Affairs, Regulatory, Clinical, Quality and Sales and Marketing concerning federal and state regulatory actions and issues – both proactively and reactively. Provide advice and counsel in various areas of US and global operations, including business development, clinical and R&D, sales and marketing, and supply chain matters. Review and advise on the Company’s response to alleged regulatory actions and violations. Serve as a member of the Promotional Review Committee for assigned products in the Ophthalmology, Gout, Rare Disease and/or inflammation business units. Serve as a key strategic advisor for proposed labeling for assigned products. Review clinical trial, vigilance and quality agreements. Collaborate with Government Affairs in analyzing and providing comments regarding proposed legislation impacting the pharmaceutical industry. This role has frequent interaction with, and provides support to, a variety of areas of Horizon Therapeutics businesses and functions, including Ethics & Compliance, Medical Affairs, Regulatory, Clinical, Quality, Supply Chain and Sales and Marketing.

Qualification and Experience

Qualifications: 4-10 years’ experience with regulatory law. Experience with FDA law (drugs, biologics and medical devices) is preferred. Excellent commercial acumen. Experience with privacy and state distribution regulations. Experience providing regulatory input for commercial contracts being handled by legal colleagues. Someone who is a good listener, and someone who is curious. Natural self-direction, with the ability to operate in ambiguity and learn quickly. Open to coaching and constructive feedback and able to adapt and apply lessons learned. Strong, pragmatic business acumen with the ability to recognize the business consequences of legal advice. Be a creative thinker with strong problem-solving skills and the ability to stay calm under pressure, handle multiple assignments simultaneously, effectively manage conflicting priorities and a dedication to continuous improvement. Highly motivated, proactive team-player with a positive attitude and desire to learn and expand skill set. Someone who collaborates easily with others, rolls up their sleeves, and is a strong team player is essential in this position. In-house experience preferred though law firm candidates will be considered.

Company info

Hiring Coordinator
Horizon Therapeutics plc
520 Lake Cook Road, Suite 520
Deerfield, IL 60015