Senior Team Leader - Regulatory Affairs, EU/UK Market

Job Description

Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities in Europe, UK. Lead the preparation, review, and submission of high-quality regulatory CMC documentation. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs). Monitor and interpret global regulatory requirements and industry trends related to CMC and life cycle management. Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations. Lead or support meetings and interactions with regulatory authorities, as required. Maintain awareness of and help implement changes related to product quality systems, quality investigations, risk assessments, and change controls. Represent Regulatory CMC in cross-functional teams and support regulatory strategy for product life cycle management plans.