Overview
An innovative organization within the biotechnology and pharmaceutical industry is seeking a Director, Senior Counsel, Regulatory & Compliance for a permanent, remote position. This role requires travel to Research Triangle Park (RTP), North Carolina, at least once a month. The Director will serve as a key legal partner to commercial and medical teams, providing strategic guidance on regulatory, compliance, and promotional activities throughout the product lifecycle.
Responsibilities
- Provide legal advice to cross-functional teams including Sales, Marketing, Medical Affairs, Patient Support, and Regulatory Affairs on FDA regulations, healthcare laws, and fraud and abuse statutes.
- Lead legal review of promotional and medical materials, participating in promotional review committees and medical communications forums.
- Support patient services and access programs by advising on reimbursement support, patient assistance initiatives, and field-based educational roles.
- Assist with compliance program oversight, including policy development, training materials, risk assessments, audits, and internal investigations.
- Monitor regulatory and enforcement trends, manage external counsel, and deliver strategic legal recommendations to business leaders and compliance committees.
Requirements
- Juris Doctor (JD) degree from an accredited law school.
- At least 10 years of legal practice experience.
- Minimum of 8 years focused on healthcare, FDA, and life sciences regulatory law.
- Preferably 4+ years of in-house legal experience within pharmaceutical or biotechnology organizations.
- Strong drafting, communication, and collaboration skills.
- Ability to work effectively in a fast-paced environment.
- Experience with promotional review systems such as Veeva PromoMats.
- Proficiency with Mac/PC platforms and Microsoft Office tools.
Compensation & Benefits
- Salary range: $230,000 to $285,000 per year (USD).
- Annual bonus of 25%.
- Comprehensive benefits including medical, dental, vision coverage, sick leave as required by law, and 401(k) retirement plan.
Location
- Remote work with required travel to RTP, North Carolina, at least once per month.
Application Details
- Applications open on April 30, 2026.
- Applications will be accepted for at least 30 days from the posting date.