Lead Specialist Regulatory Affairs

Job Description Summary The Regulatory Affairs supports regulatory activities for assigned products and markets throughout the product lifecycle. This level role is designed for an early regulatory career professional who will learn and apply country- and region-specific regulations, standards, internal procedures, and product knowledge to prepare high-quality regulatory documentation, support submissions and compliance deliverables, and contribute to timely market access and continued product compliance. Provides regulatory support for Maternal Infant Care regulatory programs across the product lifecycle, including global registration planning, submissions, notified body and quality system audits, program implementation, and pre- and post-market compliance.

The role works collaboratively across a matrixed organization and provides an opportunity to build practical regulatory expertise while contributing to go-to-market strategies and solutions for low- to moderate-complexity regulatory matters under appropriate guidance and supervision. Works across a cross-functional matrix and communicates regulatory strategy, risks, decisions, and program status to leadership and other stakeholders.