For our client, we are seeking a Senior Director – Counsel Integrated Patient Safety Regulatory Legal to join the team of a leader in the Pharmaceuticals & Biotech space. This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a Pharmaceuticals & Biotech environment. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $195,000 – $286,000 annually Responsibilities
Provide strategic legal counsel on pharmacovigilance operations and related regulatory matters
Advise product safety management teams on emerging issues and labeling language
Collaborate on clinical development activities affecting patient safety
Support AI initiatives within patient safety and offer guidance on legal implications
Ensure compliance with pharmacovigilance quality and inspection readiness standards
Monitor evolving laws in pharmacovigilance and clinical development, translating them into actionable insights
Influence regulatory policy initiatives that align with company objectives
Qualifications
Juris Doctor (JD) and Bachelor's degrees required
Licensed to practice law in at least one U.S. state
5-10 years of legal experience in a law firm or as in-house counsel in the pharmaceutical or device industry
Experience in advising on pharmacovigilance and regulatory matters preferred
Familiarity with global pharmacovigilance frameworks and AI/automation governance is a plus
Benefits
Remote/hybrid work options may be available
Expected travel is minimal, at 10-15% to global affiliates
Participation in a comprehensive benefits program including medical, dental, and vision plans
401(k) and pension eligibility
Vacation benefits and paid time off programs
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.