Lead, Global Quality Regulatory Intelligence

About the role

For our client, we are seeking a Lead, Global Quality Regulatory Intelligence to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the organization’s regulatory intelligence and external engagement efforts within a highly regulated global environment. The position focuses on tracking emerging regulations and policy trends, shaping external positions, and coordinating cross-functional input to support compliant and informed decision-making. You will partner closely with Regulatory Affairs and other internal stakeholders while engaging with health authorities, trade associations, and other external organizations. Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Develop and manage the organization’s intelligence and advocacy strategy, including governance and processes.
• Identify and assess new regulations and industry trends relevant to the company’s operations.
• Collaborate with Regulatory Affairs to align external comments and positions.
• Define and manage the communication and engagement strategy with external stakeholders.
• Lead coordination of comments on regulations and ensure stakeholder input is captured.
• Engage with external organizations to monitor policy changes and influence regulatory expectations.
• Identify opportunities for colleagues to participate in industry forums and external engagements.

Qualifications

• Several years of experience in the pharmaceutical or biopharmaceutical industry, specifically in Quality, Regulatory Affairs, or Operations.
• Direct experience with regulatory intelligence and engagement with health authorities and trade associations.
• Demonstrated experience leading global processes and cross-functional initiatives in a regulated environment.
• Strong knowledge of GMP, GDP, and GxP regulations and quality system expectations.
• Ability to work effectively in a matrixed global organization and influence without direct authority.
• Excellent written and verbal communication skills for conveying complex information clearly.
• People management experience preferred.

Pay

Compensation: $200,000 – $243,000 annually

Benefits

• Comprehensive benefits package including performance-related bonus.
• Medical and dental coverage.
• 401k plan.
• Life insurance and disability insurance options.
• Employee assistance program.
• Paid time off (PTO) for work-life balance.