SUMMARYOur client is a medium size Global CRO with a very strong presence worldwide. They have had a huge amount of success in the biotech space and are now expanding their RA function in Asia and are seeking a Mandarin speaking Head of Regulatory Affairs to lead their function.This role will carry line management responsibilities with the opportunity to build and shape the regulatory team from scratch!RESPONSIBILITIES Lead regulatory strategy and operations for global submissions (e.g., IND/CTA, amendments, orphan designations, expedited pathways). Provide expert guidance on clinical development, regulatory standards, and ICH/GCP compliance. Manage and mentor Regulatory Managers; oversee resource allocation and performance. Represent Regulatory Affairs in cross-functional and client-facing meetings. Ensure regulatory documentation meets quality and compliance standards. Support audits, policy development, and implementation of regulatory tools. Maintain expertise in international regulations and assess emerging requirements. Contribute to business development through proposal generation and strategic input.DURATIONFull-time, permanentSALARYAttractive salary + benefitsLOCATIONAPAC - fully remoteABOUT PLANET PHARMAWe are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.www.planet-pharma.com TO APPLYPlease click ‘apply’ or contact Sam Chapple (Associate Director, Recruitment - APAC) at Planet Pharma for more information:E: ***@***.***T: : +61 (0) 37 068 9299Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/

Required: Bachelor’s or postgraduate degree in science or healthcare. 10+ years in regulatory affairs within CRO, pharma, or biotech. Deep knowledge of global regulatory frameworks (FDA, EMA, APAC, ICH/GCP/GMP). Proven leadership in regulatory strategy and clinical program management. Fluent in English and Mandarin; proficient in MS Office.Preferred: Advanced degree (MD, PhD, PharmD) or RAC certification. Experience in financial oversight and team leadership.Core Competencies Strong communicator with excellent presentation and interpersonal skills. Skilled in managing complex projects and cross-functional teams. High integrity, strategic mindset, and results-driven approach. Ability to influence, delegate, and foster collaborative environments. Comfortable with ambiguity and capable of sound decision-making.