Lead, Global Quality Regulatory Intelligence (Pharmaceutical)

Location: Remote, Morristown, New Jersey, United States

Annual base salary: $200,000–$243,000 USD

Company

hirify.global is a global life sciences company providing products and services across the pharmaceutical and biopharmaceutical industry.

What you will do

• Develop and manage the global strategy, governance, tools, sources, and processes for quality regulatory intelligence, advocacy, and external engagement.
• Monitor and assess regulations, draft guidance, health authority expectations, industry trends, and policy developments.
• Coordinate cross-functional comments and advocacy positions with Quality, Regulatory Affairs, Operations, R&D, site teams, and subject matter experts.
• Manage engagement with health authorities, trade associations, professional organizations, conferences, working groups, and industry forums.
• Establish and oversee a sustainable global quality system for integrating intelligence into procedures, training, business processes, and supporting IT systems.
• Report process effectiveness, escalate emerging risks, support inspection readiness, and contribute to responses to health authority observations.

Requirements

• Several years of experience in the pharmaceutical or biopharmaceutical industry across Quality, Regulatory Affairs, Operations, R&D, or related regulated functions.
• Direct experience with regulatory intelligence, external monitoring, impact assessment, policy, advocacy, or engagement with health authorities and trade associations.
• Experience leading global or enterprise-wide processes, governance forums, improvement initiatives, or cross-functional programs.
• Strong knowledge of GMP, GDP, GxP regulations, and global quality system expectations.
• Strong strategic, analytical, communication, change management, and stakeholder engagement skills in a matrixed global organization.
• Experience with regulatory authorities, health authority publication processes, regulatory intelligence systems, information management tools, analytics, or automation.

Nice to have

• People management experience.

Culture & Benefits

• Full-time employment in a global life sciences organization.
• Performance-related bonus and comprehensive benefits package.
• Medical and dental coverage, 401(k) plan, life insurance, and disability insurance.
• Employee assistance program and paid time off.
• Work focused on ethical practices, scientific innovation, and improving lives through life sciences.