RegulatoryAffairsPharmacovigilanceManager

## Accountabilities Lead and support regulatory strategy development for Expanded Access Programs (EAPs), including programs involving biologics, cell and gene therapies, and synthetic drugs. Serve as a regulatory and pharmacovigilance subject matter expert in client communications, health authority interactions, audits, and cross-functional project meetings. Prepare, compile, and submit complete regulatory dossiers for both cohort-based and named-patient EAPs on behalf of clients. Contribute to the design and execution of regulatory approaches for EAP setup, including geographic and operational considerations. Ensure timely, accurate, and compliant execution of all regulatory and pharmacovigilance activities related to EAP operations. Collaborate closely with Medical Affairs, Quality Assurance, Program Management, Supply Chain, and Commercial teams to ensure seamless program delivery. Maintain up-to-date knowledge of global regulations and guidelines impacting Expanded Access and ensure internal alignment with evolving requirements. Support the development, review, and maintenance of regulatory documentation, templates, SOPs, CAPAs, and quality systems. Liaise with pharmacovigilance service providers to ensure end-to-end compliance and alignment of safety reporting processes. Requirements: Approximately 5 years of experience in Regulatory Affairs, with direct exposure to Expanded Access Programs strongly preferred. Solid foundational knowledge of Pharmacovigilance principles and global safety reporting requirements. Strong understanding of national and international regulations governing Expanded Access and related regulatory frameworks. Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline. Proven experience working with external stakeholders, including pharmaceutical clients or regulatory authorities. Excellent written and verbal communication skills in English, with the ability to translate complex regulatory conc