Associate Counsel - Regulatory
Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: June 17, 2022
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
- 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
- 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
- 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
- Review clinical trial, vigilance and quality agreements.
- Collaborate with Government Affairs in analyzing and providing
comments regarding proposed legislation impacting the
- 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)
- Excellent commercial acumen.
- Experience with privacy and state distribution
- Experience providing regulatory input for commercial contracts
being handled by legal colleagues.
- Someone who is a good listener, and someone who is
- 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
- 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
- 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
Keywords: Horizon Therapeutics, Mount Prospect , Associate Counsel - Regulatory, Legal , Mount Prospect, Illinois
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