United Therapeutics Corporation · 9 hours ago
Director, Senior Counsel - Regulatory & Compliance
Triangle Area
Full-time
Hybrid
Director/Executive
$230K/yr - $285K/yr
10+ years expUnited Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies to expand organ availability for transplant. The Director, Senior Counsel - Regulatory & Compliance is responsible for managing legal, regulatory, and compliance issues within the pharmaceutical and biotech industry, providing expert legal support across various departments related to healthcare laws and regulations.
BiotechnologyPharmaceuticalTherapeutics
Responsibilities
Provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
Serve as a Legal representative on the Company's promotional review committee, including review of promotional and sales training materials
Provide legal support for the Company’s Patient Relations function, including providing advice related to reimbursement support, patient support programs, therapy access managers, patient navigators, and nurse educators
Review Needs Assessment Forms related to HCP consulting activities and associated materials
Serve as a Legal representative on the Company’s medical communications review team, including review of Field Medical materials, medical information letters, health economic related materials, and social media posts
Assist with reviewing, drafting and/or revising compliance related policies and standard operating procedures, as well as corresponding training materials
Assist with privileged compliance audits and investigations, including the development of any corresponding corrective action plans
Provide guidance to the Company’s Compliance Committee, as needed
Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on levels of risk and corresponding risk mitigation activities
Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed of the same
Manage outside counsel on compliance and regulatory matters
Provide backup legal support for general corporate legal issues as required
Perform all other related duties as assigned
Qualification
Required
Juris Doctorate (JD) from an accredited law school
10+ years of experience as an attorney
8+ years of experience in healthcare and FDA law
4+ years of experience as in-house counsel at a pharmaceutical or biotech company
Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products
Effective communicator and collaborative team member
Strong written communication and drafting skills
Mac/PC and MS Office proficient
Ability to work in a fast-paced, dynamic environment
Candidates preferred location is EST
Must be able to travel to RTP, NC at a minimum of one week per month
Preferred
Experience with Veeva PromoMats
Benefits
Medical, dental, & vision healthcare
Savings plans (401 (k) and ESPP)
Employee wellness resources
Paid time off & paid parental leave
Disability benefits
More
Company
United Therapeutics Corporation
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2026-01-15
2026-01-09
Company data provided by crunchbase