Overview
A leading organization in the pharmaceutical and biotechnology industry is seeking a Director of Senior Counsel, Regulatory & Compliance. This role involves providing strategic legal and compliance guidance across commercial and medical functions throughout the product lifecycle. The position is a direct placement, offers remote work during Eastern Standard Time hours, and requires monthly travel to Raleigh, North Carolina.
Responsibilities
- Provide legal guidance on FDA and healthcare laws, including the Federal Food, Drug, and Cosmetic Act (FDCA), False Claims Act, Anti-Kickback Statute, Sunshine Act, Office of Inspector General (OIG) Guidance, and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code
- Serve on promotional review and medical communications review committees
- Support Sales, Marketing, Medical Affairs, Patient Relations, Regulatory, and Compliance teams
- Advise on patient support programs, reimbursement initiatives, and healthcare provider consulting activities
- Assist with compliance policies, standard operating procedures (SOPs), training, audits, and investigations
- Manage outside counsel and monitor regulatory and enforcement changes
Requirements
- Juris Doctor (JD) degree from an accredited law school
- Minimum of 10 years of legal experience, including at least 8 years focused on healthcare and FDA law
- At least 4 years of in-house counsel experience within pharmaceutical or biotechnology sectors preferred
- Experience with Veeva PromoMats preferred
- Strong written and verbal communication skills
- Ability to work remotely within the U.S. (preferably Eastern Standard Time) and travel to Research Triangle Park, NC one week per month
Compensation & Benefits
- Base salary range: $230,000 to $285,000
- Bonus: 25% of base salary
- Equity participation
- Comprehensive benefits package including health, vision, dental insurance, paid time off, paid holidays, and sick leave as required by law
Location
Remote work with required monthly travel to Raleigh, North Carolina
Application Information
Applications open on April 30, 2026, and will be accepted for at least 30 days from the posting date.