Overview I am seeking a highly experienced CMC and Regulatory Affairs Principal Consultant to join a global regulatory consultancy during a pivotal phase of growth. This is a full-time hybrid position open to candidates based anywhere within Australia. The role offers the opportunity to shape regulatory strategy for complex products while mentoring and developing a high-performing team. I am looking for someone with deep expertise in CMC development and regulatory affairs, backed by a minimum of ten years of experience in regulatory submissions and agency interactions. You should be confident navigating FDA, EMA, and ICH guidelines and skilled in developing product strategies for biologics, vaccines, and advanced therapies. In this role, you will lead cross-border programs, author and review high-impact regulatory documents, and represent clients in agency meetings. A strong background in consultancy, strategic planning, and team leadership is essential for success. If you are ready to bring your expertise to a dynamic and collaborative environment, I invite you to apply today. CEI: R2090154 | Licence No.: 22S1313 Seniority level Mid-Senior level Employment type Full-time Job function Science Industries Business Consulting and Services J-18808-Ljbffr
