Regulatory Affairs Associate

Join to apply for the Regulatory Affairs Associate role at Novartis This is a temporary contractor opportunity at Novartis Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit. Ready to work with/through Magnit at Novartis? Please read on… Job Purpose Provide operational support to RA Regions. Responsible for organization and coordination of business critical documents, required for regulatory submissions in Rest of the world countries. In addition, responsible for managing legalization of these documents when required. Major Accountabilities Support regulatory activities (New MAAs, line extensions, renewals, CMC changes, Safety Label Changes) in Rest of World countries, by ensuring timely and accurate availability of business critical documents, not provided as part of the core dossier Manage and coordinate process for Apostille or legalization of business critical documents required to support regulatory activities in Rest of World countries Manage relationship to external vendors providing legalization and notary services – act as Single Point of Contact with these vendors Manage and coordinate process for Letters of Authorization, required by Health Authorities to support regulatory activities in Rest of World countries Coordinate and facilitate timely delivery of business critical documents to CPOs worldwide Manage tracking of all legalization and dispatch activities, ensuring accurate and timely oversight available to relevant business partners Provide operational support to RA Regions, e.g. maintaining generic mailbox, maintaining archive, organizing meeting support, coordination of signatures Provide training on declaration letters and legalization process to RA Regions and key stakeholders as needed Provide additional operational support to RA MOW, as required Requirements Language: English required; German is a plus. Education: Bachelor’s degree preferred. Technical and software skills: Proficient in MS Office, Teams, Outlook etc. Soft skills: Strong communication, coordination, and planning abilities; reliable and proactive in addressing issues. Preferred experience: Prior administrative experience, experience with HA document handling is a plus. Workload: 100% (40 hours per week) Role type: Hybrid (3 days/week onsite) Required start date: January 2026 Contract: 2 years Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com. Job Details Seniority level: Not Applicable Employment type: Contract Job function: Legal Industry: Pharmaceutical Manufacturing #J-18808-Ljbffr