Novartis Require Regulatory Coordinator - Chemistry, Pharmacy, Biochemistry, Biotechnology Degree Apply

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Regulatory Coordinator

Job Description
About the Role :
Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

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.

Candidate Profile
• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Minimum of 3-5 years of experience in Regulatory Affairs, 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

Additional Information
Experience : 3-5 years years
Qualification : Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology)
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : REQ-10063144
End Date : 25th October 2025