Job
Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Provide and ensure timely preparation of high quality CMC regulatory documentation and support in line with US and Canada market regulatory submission plans and strategies. Roles and responsibilities: Life cycle management of Marketing Authorizations (MAs). Core experience on PLCM submissions and deficiency responses for US markets, Grouped Supplement and Canada-sANDS/ sNDS filings. Responsible for MA transfers and maintaining product history as per defined timelines and processes. Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. Prepare CMC responses to health authority questions during development, registration and product lifecycle. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc) for possible regulatory impact. Experience on managing administrative changes will be an added advantage. Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. Establish and maintain sound working relationships with partners, stakeholders and customers. Review of quality regulatory PLCM submissions and deficiency responses for global markets (US- CBE0, CBE30, PAS, Grouped Supplement and Canada- sANDS/ sNDS filing). Assume activities in support of the global databases and quality systems. Interactions with Agency as and when required as per business requirements. Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management). Training and mentoring Junior associate. Reviewing of the regulatory applications and variation packages prepared by associates. Regulatory project management. What you’ll bring to the role: Postgraduate in Pharmacy or Science (e.g. Analytical chemistry) or equivalent. Additional courses in Drug Product Regulatory Affairs would be added advantage Minimum 10+ years of experience in core Reg CMC areas Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! #Sandoz Show more Show less
