Regulatory - Associate Counsel - Now Hiring
Company: Horizon Therapeutics
Location: Vernon Hills
Posted on: June 19, 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.
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
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.
- 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
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
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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.Required
Keywords: Horizon Therapeutics, Arlington Heights , Regulatory - Associate Counsel - Now Hiring, Other , Vernon Hills, Illinois
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