GRA CMC Scientist

CSL, a global biopharmaceutical organization focused on saving lives, is looking for two GRA CMC Scientists. The roles can be based in Bern (Switzerland), Waltham (USA) or Melbourne (Australia) and will support the creation and maintenance of regulatory pathways for innovative biologic medicines. In this position you will shape and execute worldwide CMC regulatory plans for new product programs, clinical trial filings, marketing authorisations and post‑approval modifications. You will organise the creation, review and upkeep of all CMC paperwork required for international submissions, keeping dossiers accurate and compliant throughout each product's life. Collaboration with technical, manufacturing and regulatory colleagues will be essential to evaluate changes in facilities, equipment or processes and to determine their regulatory impact. You will also draft and assess content for marketing and clinical applications, respond to health‑authority queries, contribute to risk assessments, and help the team stay ready for inspections while continuously improving regulatory workflows. Successful candidates will hold a university degree in a scientific area such as biotechnology, biological sciences, chemistry, pharmacy or a closely related discipline. At least three years of experience in the biotech, pharmaceutical or comparable life‑science sector is required, together with hands‑on work in regulatory affairs, CMC, manufacturing, quality or process development. A solid grasp of the rules governing biological medicinal products and specific familiarity with the Australian regulatory system and submission preparation are expected. Strong written and verbal communication, stakeholder‑management, planning, project‑management and organisational abilities are vital, as is an analytical mindset and the capacity to solve problems and influence diverse, global teams. The positions offer the chance to work in a highly collaborative, multinational environment, partnering with experts across the company to bring life‑changing therapies to patients. Being based at any of the three locations provides exposure to different regulatory landscapes while contributing to CSL's mission of protecting health worldwide. What the role asks for: - Degree in Biotechnology, Biological Sciences, Chemistry, Pharmacy or related field - Minimum three years experience in biotech/pharma or life‑science industry - Experience in Regulatory Affairs, CMC, manufacturing, quality or process development - Knowledge of regulatory requirements for biological medicinal products - Familiarity with Australian regulatory framework and submission preparation - Strong communication and stakeholder‑management abilities - Proven planning, project‑management and organisational skills - Analytical thinking and problem‑solving capability - Ability to influence and collaborate across global teams - Nice‑to‑have: willingness to work from Bern, Waltham or Melbourne