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NOVARTIS
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Regulatory Coordinator

Regulatory Coordinator

NOVARTIS

3 - 5 years

5 - 7 Lacs

Hyderabad

Posted:21 hours ago| Platform:

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Skills Required

Procurement Manager Quality Assurance Networking Pharmacy Diversity and Inclusion Biochemistry GMP SCM Operations Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Summary

The Regulatory Coordinator (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:

Degree in Science (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Minimum of 3-5 years of experience in R egulatory A ffairs, related areas of the pharmaceutical Industry
Good interpersonal and communication skills
Ability to plan and prioritize work
Ability to work effectively in a matrix environment
Fluency in English written and spoken

Why Novartis:

Commitment to Diversity and Inclusion:

Accessibility and accommodation
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:

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Regulatory Coordinator