Manager, Regulatory Intelligence

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and lead designated global surveillance workstreams, autonomously monitoring, interpreting, and conveying evolving regulatory requirements.

• Supervise monitoring of compendial changes, chemical mandates, pharmaceutical and non-pharmaceutical packaging, diagnostics, medical devices, and GMP/Environmental inspection activities.

• Facilitate cross-functional impact assessments alongside EHS, VMRD, Quality, Global Manufacturing, Public Affairs, and Legal teams.

• Ensure that assessments are finalized, compliance plans are documented, and action items are tracked to completion.

• Spearhead the creation and distribution of regulatory intelligence newsletters, regulatory watch notifications, and responses to ad hoc queries.

• Review and perform quality checks on regulatory intelligence communication outputs produced by team members.

• Coordinate company responses to draft guidance, standards, and consultations.

• Manage Subject Matter Expert (SME) engagement, consolidate inputs, and ensure submissions present a clear and defensible company stance.

• Represent the company in relevant industry associations and regulatory forums.

• Oversee EPR reporting data submissions through timely and accurate filing with state and/or national programs.

• Act as a subject matter expert on new and emerging regulations or requirements as necessary.

• Coordinate external consultant activities, including defining scope, reviewing and approving budgets, and maintaining ongoing communication.

• Serve as the primary point of contact for specific internal stakeholder groups regarding regulatory intelligence-related inquiries.

• Analyze regulatory compliance trends, assess emerging risks, and prepare action plans and briefings for governance forums.

• Contribute to the design, documentation, and sustainability of regulatory intelligence processes and Standard Operating Procedures (SOPs).

• Advocate for AI-enabled regulatory intelligence platforms and assist in the selection, piloting, implementation, and training on regulatory intelligence-specific digital tools.

⛳️ Requirements

• Bachelor’s degree in a scientific field (e.g., life sciences, pharmacy, regulatory affairs, or a related discipline).

• A minimum of 5 years of experience in Regulatory Affairs or a related area.

• Proven history of independently managing regulatory deliverables and leading cross-functional workstreams or serving as a Subject Matter Expert within a cross-functional team.

• Experience with regulatory intelligence systems or tools is essential at this level.

• Previous interactions with the FDA, USDA, or other U.S. authorities are highly preferred.

• Experience in a Regulatory Intelligence function is preferred.

• General knowledge of (bio) pharmaceutical research and development, authorization, and post-marketing compliance of medicinal products.

• A solid understanding of Chemistry, Manufacturing, and Controls (CMC) is preferred.

• Experience as an active participant or representative in industry associations, demonstrating contributions to working groups or policy discussions.

• Working knowledge of animal health product laws, regulations, and the regulatory policymaking process.

• Understanding of laws and regulations pertaining to chemical substances.

• Familiarity with sustainability and packaging regulations, including U.S. State EPR reporting frameworks and PRO data submission requirements.

• Experience managing a portfolio of regulatory liaison activities directly with Global Health Authorities.

• Practical experience with AI software and GenAI technology applied to regulatory intelligence workflows.

• All applicants must have or be able to obtain authorization to work in the U.S. for Zoetis; individuals needing sponsorship must disclose this information.

🏝️ Benefits

• Short-term incentive compensation.

• Long-term incentives.

• Healthcare and insurance benefits starting on day one.

• 401K plan with matching and profit-sharing contributions from Zoetis.

• Four weeks of vacation.