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
The manager leads the following workstreams:
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External Consultation Responses: Coordinate timely company responses to draft guidance, standards, and consultations.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:…