Associate Counsel, Regulatory

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 9, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

The Regulatory Counsel provides legal counsel to business colleagues regarding applicable FDA regulatory and other state and federal legal requirements, combining their legal expertise with their strong business acumen and grasp of the organization's risk tolerance profile.

Serves as the legal representative on the Promotional Review Committee for products and/or business units they are designated to support, as well as other legal-regulatory matters as they arise for those products/business units.

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 Horizon Therapeutics' 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.

Qualifications and Skills Required:
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 his/her 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.

Horizon Core Values & Competencies:

Growth
Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent

Accountability
Drives Results Ensures Accountability Decision Quality

Transparency
Courage Collaboration Instills Trust

Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Buffalo Grove , Associate Counsel, Regulatory, Legal , Buffalo Grove, Illinois