Regional Regulatory Affairs Manager – Biologics & Vaccines

CSL is seeking a Manager, Regional Regulatory Lead to drive regulatory strategy for our biotherapies, vaccines, and plasma-derived therapies across assigned regions. In this role, you will lead the planning, preparation, and submission of regulatory dossiers, ensure compliance with global and regional requirements, and serve as a key liaison with health authorities. You will provide strategic regulatory guidance to cross-functional teams, monitor evolving regulations, and support inspections and audits. This position offers the opportunity to contribute directly to life‑saving therapies in a patient‑focused, science‑driven, and collaborative environment. Lead regional regulatory strategy for CSL’s biotherapies, vaccines, and plasma-derived products Liaise with FDA and other health authorities to support product approvals and lifecycle management Ensure compliance with global and regional regulatory requirements and internal standards Drive preparation, review, and submission of regulatory dossiers and responses Provide regulatory guidance to clinical, CMC, safety, and commercial teams Monitor and interpret evolving regulatory guidelines and assess business impact Represent Regulatory Affairs in cross-functional project teams and governance forums Support inspections, audits, and remediation activities as needed Regulatory strategy development FDA and EMA regulations ICH guidelines Biologics and vaccines regulatory pathways Regulatory submissions (IND/CTA, BLA/MAA) Cross-functional leadership Risk assessment and mitigation Scientific writing and documentation Regulatory intelligence and policy interpretation Project management Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k Regulatory Affairs Certification (RAC) preferred Advanced knowledge of FDA, EMA, and ICH regulations and guidance Experience with regulatory submissions (IND/CTA, BLA/MAA, variations) Background in biotechnology, pharmaceuticals, or related life sciences