Sr Regulatory Coordinator

Summary

The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and / maintenance projects through development, registration, and approval including post approval commitments.

To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects.

About The Role

Key Responsibilities

• Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA's and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders : NTO, Reg CMC, Global labelling & RA Ops for renewals, SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic / EMA & Consular Services for certificates etc, External Service providers
• Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions word wide (as per health authority requirements).
• For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings, RA global and regional team meetings.
• Organize regulatory readiness with relevant line functions and with Country Organizations & Regions for timely delivery of submission and approvals
• Track progress of assigned projects, including timelines and dossier deliveries.
• Ensure quality and compliance with global regulatory requirements, countries requirements and adherence to regulatory internal policies and processes
• Support for maintaining country requirement lists and conducting need-based surveys & interaction with country organizations.
• Contribute to non-project related initiatives and excellence activities
• Support lessons learned sessions and trainings within and external to RA GDD leading to improve strategies and decisions on common regulatory approaches.

Minimum Requirements

Why Novartis

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here : https : / / www.novartis.com / about / strategy / people-and-culture

You'll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https : / / www.novartis.com / careers / benefits-rewards

Commitment To Diversity And Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams&apos representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here :

https : / / talentnetwork.novartis.com / network

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 https : / / www.novartis.com / about / strategy / people-and-culture

Join our Novartis Network : Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up : https : / / talentnetwork.novartis.com / network

Benefits and Rewards : Read our handbook to learn about all the ways we'll help you thrive personally and professionally : https : / / www.novartis.com / careers / benefits-rewards

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Skills Required

Regulatory Affairs