Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Following a new opportunity, we are currently looking for a CMC Regulatory Specialist with a strong background in regulated industrial environments, ideally within pharmaceutical, biotech or life sciences manufacturing, to support our projects in Sydney, NSW, Australia. You’ll be responsible for Preparing, reviewing, and submitting CMC regulatory documents (e.g., CTAs, NDAs, MAAs, variations). Supporting CMC, MSAT, and Product Development (PD) activities across the product lifecycle within the Life Sciences sector. Collaborating with Manufacturing, MSAT, QA, and Product Development teams on tech transfer, process validation, manufacturing changes, and scale-up activities. Managing document control and change management to ensure compliance. Maintaining and updating regulatory databases and eCTD platforms. Supporting cross-functional teams (RA, QA, Clinical, Manufacturing) for timely submissions. Assisting with audits and inspections related to CMC and regulatory compliance. Monitoring regulatory updates and guiding teams on compliance requirements. About You Minimum 3-4 years of experience in CMC Regulatory Affairs, MSAT, Product Development, or Regulatory Support within pharma, biotech, or medical device companies. Background or exposure to MSAT, tech transfer, process validation, manufacturing support, or product development activities in the Life Sciences sector. Hands‑on experience with CMC documentation, eCTD systems, or regulatory databases. Good knowledge of GxP, ICH, FDA/EMA regulations. Experience in document management, tracking submissions, and regulatory compliance. Strong attention to detail and ability to manage multiple priorities. Fluent in English, strong communication and collaboration skills. Location Sydney, Australia Availability 100% on site #J-18808-Ljbffr