Manager, Regulatory Intelligence

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

📋 Description

• Take ownership and lead designated global regulatory surveillance initiatives, primarily focusing on the USA and Canada.

• Monitor, interpret, and convey changing regulatory requirements related to compendial modifications, chemical specifications, packaging, diagnostics, medical devices, and GMP/Environmental inspection activities.

• Coordinate cross-functional impact evaluations involving EHS, VMRD, Quality, Global Manufacturing, Public Affairs, and Legal teams.

• Ensure that compliance plans are well documented and that actions are tracked to completion.

• Create and distribute newsletters on regulatory intelligence, regulatory watch updates, and responses to ad hoc inquiries.

• Review and conduct quality checks on regulatory intelligence communications generated by team members.

• Manage company responses to draft guidance, standards, and consultations.

• Oversee engagement with Subject Matter Experts (SMEs), consolidate their inputs, and ensure submissions accurately represent a clear and defensible company stance.

• Represent the company in industry associations and regulatory forums; actively contribute to working groups and industry-wide regulatory positions.

• Manage obligations related to Producer Responsibility Organizations and Extended Producer Responsibility reporting, including data submissions to state and/or national programs.

• Occasionally serve as a subject matter expert on new and emerging regulations or requirements.

• Coordinate activities of external consultants, including defining scopes, reviewing and approving budgets, and acting as a liaison.

• Act as the primary point of contact for designated internal stakeholders regarding regulatory intelligence inquiries.

• Analyze compliance trends, evaluate 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 support their selection, piloting, implementation, and training for the team.

⛳️ Requirements

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

• At least 5 years of experience in Regulatory Affairs or a related field.

• Proven ability to independently manage regulatory deliverables and lead cross-functional initiatives or serve as a Subject Matter Expert within a cross-functional team.

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

• Prior interactions with FDA, USDA, or other US regulatory authorities are highly preferred.

• Experience in a Regulatory Intelligence function is preferred.

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

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

• Experience as an active participant or representative in industry associations, with a proven contribution to working groups or policy discussions.

• Working knowledge of animal health product laws, regulations, and the regulatory policy-making process.

• Understanding of chemical substances laws and regulations.

• Familiarity with sustainability and packaging regulations, including US State Extended Producer Responsibility reporting frameworks and Producer Responsibility Organization data submission requirements.

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

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

• All applicants must possess or obtain authorization to work in the US for Zoetis.

🏝️ Benefits

• Short-term incentive compensation.

• Long-term incentives.

• Healthcare and insurance benefits available from day one.

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

• Four weeks of vacation.