Director, Senior Counsel - Regulatory & Compliance

Overview

A leading organization in the Pharmaceuticals & Biotech sector is seeking a Director Senior Counsel - Regulatory & Compliance. This role involves delivering legal and compliance outcomes for customers and stakeholders, collaborating cross-functionally, and managing key priorities. The position offers significant visibility, growth opportunities, and impact within the industry.

Location: Remote (U.S. based candidates only; no visa sponsorship available)

Compensation: $230,000 – $285,000 annually

Responsibilities

• Provide legal guidance to Marketing, Sales, Medical Affairs, and Compliance teams on healthcare laws
• Represent the legal department on the promotional review committee for marketing materials
• Support Patient Relations concerning reimbursement and patient programs
• Review consulting-related Needs Assessment Forms and associated materials
• Contribute to medical communications review across various content outputs
• Draft and revise compliance policies and training materials as needed
• Assist in compliance audits and develop corrective action plans
• Advise the Compliance Committee as necessary
• Oversee the annual Risk Assessment process and mitigation strategies
• Monitor and communicate regulatory changes to business leaders
• Manage outside counsel on compliance and regulatory matters
• Provide legal support for general corporate issues as required

Qualifications

• Juris Doctorate (JD) from an accredited law school
• Minimum of 10 years of experience as an attorney
• At least 8 years of experience in healthcare and FDA law
• Minimum of 4 years as in-house counsel within pharmaceutical or biotech companies
• Strong understanding of legal aspects throughout the product lifecycle
• Effective communication and collaboration skills
• Excellent drafting and written communication abilities

Desired Skills and Experience

• Knowledge of the Food, Drug, and Cosmetic Act, False Claims Act, Anti-Kickback Statute, and Sunshine Act
• Familiarity with Veeva PromoMats, Healthcare Compliance Management Systems, Regulatory Affairs systems, Medical Information databases, Legal Document Management Software, and Training and Compliance platforms
• Experience with collaboration tools such as Microsoft Teams or Zoom
• Competence in data analytics for compliance and risk assessment
• Understanding of biopharmaceutical industry standards

Benefits

• Comprehensive medical, dental, and vision healthcare coverage
• Employee wellness resources
• 401(k) plan and Employee Stock Purchase Plan (ESPP)
• Paid time off and paid parental leave
• Disability benefits
• Short-term and long-term incentive programs

Equal Opportunity

The employer is an equal opportunity organization and encourages applications from candidates who may not meet every qualification but whose backgrounds could be a strong fit for the team.