Senior Manager, Regulatory Affairs CMC

Job description

Band Level 4 Job Description Summary: #LI-Hybrid (12 days per month on-site) Office Location: Schaftenau, Austria Novartis are seeking a Senior Manager to be responsible for regulatory activities related to Chemistry, Manufacturing and Controls (CMC), including the preparation and publication of CMC regulatory documentation for Health Authority submissions. The role also involves engaging with Health Authorities on CMC‑related questions to support both new product launches and post‑marketing activities. Job Description: Major Accountabilities: Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance. Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guid...