Manager Regulatory Intelligence

Zoetis; Parsippany-Troy Hills (NJ); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health benefits

401K with match

4 weeks vacation

Résumé du poste

Zoetis in Parsippany-Troy Hills, NJ, United States, seeks a Manager in Regulatory Intelligence to independently own surveillance workstreams and serve as the RI partner for defined stakeholder groups. You will coordinate cross‑functional impact assessments, drive RI communications, and contribute to process improvements across Global Regulatory Affairs.

The role requires a Bachelor's in a life sciences field and 5+ years in Regulatory Affairs with experience in RI systems.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 5 years in Regulatory Affairs or related field.
• Experience managing regulatory deliverables and cross-functional workstreams.

Responsabilités

• Lead global surveillance workstreams and communicate evolving regulatory requirements.
• Coordinate impact assessments with cross-functional partners to ensure compliance plans.
• Develop RI communications and newsletters; review outputs for quality and defensibility.
• Represent the company in regulatory forums and industry associations.
• Manage external consultant activities and oversee RI projects to time and budget.

Connaissances

Global surveillance

Regulatory affairs

Cross-functional leadership

Regulatory intelligence

Formation

Bachelor's degree in life sciences

Outils

AI tools

Regulatory intelligence systems

Description du poste

The Manager in Regulatory Intelligence (RI) is a lead-level contributor within Global Regulatory Affairs who independently owns assigned surveillance workstreams and serves as the primary regulatory intelligence partner for defined stakeholder groups and geographic regions. This role moves beyond task execution: the manager coordinates cross-functional impact assessments, steers the development of RI communications, and actively contributes to process improvement across the function. The manager operates with a high degree of independence, managing deliverables across multiple regulatory domains while building and maintaining strong relationships with internal SMEs, industry associations, and relevant regulators. The manager is expected to bring sound judgment, a global compliance mindset, and the ability to translate complex regulatory signals into actionable guidance for the business. From time to time the manager will need to act as subject matter expert on new and emerging topics or requirements within the company.

Position Responsibilities

• Global Surveillance Leadership (USA & Canada focus): Own and lead assigned global surveillance workstreams, independently monitoring, interpreting, and communicating evolving regulatory requirements to the broader Global Regulatory Affairs team.
• Surveillance Scope: Oversee monitoring across compendial changes, chemical requirements, pharmaceutical and non‑pharmaceutical packaging, diagnostics, medical devices, and GMP/Environmental inspectional activities.
• Cross‑Functional Impact Assessment Coordination: Take the lead role in coordinating impact assessments of new or changed requirements, working with cross‑functional partners (EHS, VMRD, Quality, Global Manufacturing, Public Affairs, Legal). Ensure assessments are completed, compliance plans are documented, and actions are tracked to closure.
• Regulatory Intelligence Communications: Lead the development and distribution of regulatory intelligence newsletters, regulatory watch notifications, and ad hoc query responses. Review and quality‑check RI communication outputs produced by team members.
• External Consultation Responses: Coordinate timely company responses to draft guidance, standards, and consultations. Manage the process of engaging SMEs, consolidating inputs, and ensuring submissions reflect a clear, defensible company position.
• Industry Association Representation: Represent the company in relevant industry associations (e.g., AHI) and regulatory forums. Contribute to working groups and help shape industry‑level regulatory positions.
• EPR Reporting & Producer Responsibility Administration: May serve as the internal administrator for Producer Responsibility Organization (PRO) obligations. Manage data submission of Extended Producer Responsibility (EPR) reporting data through timely and accurate filing with state and/or national programs, coordinating with relevant internal functions (Regulatory Affairs, EHS, Legal, Packaging, Supply Chain) to gather required data and ensure program compliance.
• Subject Matter Expert: based on the company needs, for new and emerging regulations or requirements, act on occasion and on temporary basis as the designated subject matter expert on cross‑functional project teams, governance bodies, and working groups.
• External Consultant Management: Coordinate external consultant activities including scope definition, budget review and approval, and ongoing liaison to ensure project deliverables are met on time and within budget.
• Inquiry Management: Serve as the primary point of contact for specific internal stakeholder groups for RI‑related inquiries; coordinate timely and well‑documented responses to changing regulatory requirements.
• Risk & Compliance Trending: Interpret regulatory compliance trends, assess emerging risks, and prepare action plans and briefings for Governance forums. Bring forward risks proactively rather than reactively.
• Process Improvement: Contribute to the design, documentation, and sustainability of RI processes and SOPs. Identify gaps and propose solutions to continuously improve team effectiveness.
• AI & Technology Tools: Champion the use of AI‑enabled regulatory intelligence platforms. Lead or contribute to the selection, piloting, and implementation of RI‑specific digital tools; train team members on new capabilities.

Education & Experience Required

• Bachelor's degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field).
• Minimum 5 years of experience in Regulatory Affairs or related field.
• Demonstrated track record of independently managing regulatory deliverables and leading cross‑functional workstreams or to act as Subject Matter Expert within a cross functional team.
• Experience with regulatory intelligence systems or tools required at this level.

Desirable Attributes

• Master's, or PhD degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field).
• Previous interactions with FDA, USDA, or other US authorities strongly 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. Good understanding of CMC is preferred.
• Experience as an active participant or representative in industry associations (e.g., AHI, Animal Health Europe, EFPIA, PhRMA, ISPE, PDA) with demonstrated 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 EPR reporting frameworks and PRO data submission requirements.
• Experience managing a portfolio of regulatory liaison activities directly with Global Health Authorities.
• Hands‑on experience with AI software and GenAI technology applied to regulatory intelligence workflows.

The US base salary range for this full‑time position is $120,000- $180,000. This position is also eligible for short‑term incentive compensation. This position is also eligible for long‑term incentives. In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit‑sharing contribution from Zoetis, and 4 weeks of vacation. Visit zoetisbenefits.com to learn more.

Full timeRegularColleague

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