Junior Manager – Regulatory Affairs Hiring at Syngene International, Bangalore

Junior Manager, Regulatory Affairs – Syngene International, Bangalore

Apply now for Regulatory Affairs roles at Syngene in Bangalore. Vacancies for B.Pharm, M.Pharm, and Life Sciences graduates with 6-13 years of experience in CMC regulatory affairs for global markets.

Exciting Opportunity for B.Pharm, M.Pharm & Life Sciences Graduates: Junior Manager – Regulatory Affairs at Syngene, Bangalore

If you’re an experienced professional with a strong background in CMC Regulatory Affairs, Syngene International is hiring for the position of Junior Manager – Regulatory Affairs at its Biocon SEZ facility in Bangalore. This role is ideal for those looking to make an impact in the pharmaceutical industry, particularly in regulatory filing and lifecycle management for global markets.

About Syngene International

Syngene is an innovation-led contract research, development, and manufacturing organization. With operations spanning from early discovery to commercial supply, Syngene has established itself as a global leader in integrated scientific services. Safety, compliance, and excellence are the cornerstones of Syngene’s operations.

Role Overview: Junior Manager – Regulatory Affairs

Key Responsibilities:

• Provide regulatory support across all stages of drug development for both novel and generic products.
• Lead activities related to eCTD filing, document management systems (RDMS/EDMS), and quality management systems (QMS).
• Compile, author, and publish eCTD dossiers for US, EU, and other developed markets.
• Interact with cross-functional teams to gather documentation, assess regulatory risks, and respond to regulatory authority queries.
• Maintain product marketing authorizations, regulatory databases, and update dossiers per latest guidelines.
• Review plant and R&D documents such as BMR, BPR, validation reports, and specifications.
• Provide strategic regulatory inputs and ensure continuous compliance.
• Train teams in regulatory processes and maintain SOPs.
• Follow EHS (Environment, Health, and Safety) protocols and attend safety training sessions.

Required Qualifications

Educational Background:

• B.Pharm / M.Pharm / Life Sciences degree

Experience:

• 6 to 13 years of experience in CMC Regulatory Affairs for APIs/Formulations (preferably injectables)
• Hands-on experience in filing IND, NDA, ANDA, MAA dossiers
• Familiarity with investigational medicinal products and marketing authorization procedures
• Experience with biologicals, ADCs, and veterinary drugs is a plus

Skills:

• Proficient in eCTD filing systems and regulatory software (RDMS, EDMS, QMS)
• Strong understanding of CMC requirements for global regulatory filings
• Excellent communication and document review skills

Why Join Syngene?

• Work in a world-class pharma R&D environment
• Opportunity to influence global regulatory strategies
• Safety-first culture and structured professional development
• Be part of a company committed to innovation, integrity, and excellence

Location & Application Details

• Job Location: Syngene International Ltd, Biocon SEZ, Bommasandra Industrial Area, Bangalore, Karnataka
• Position Title: Junior Manager – Regulatory Affairs
• Employment Type: Full-time

Call to Action

📌 Apply Now on Syngene Careers Portal

Join Syngene and be a part of advancing life-saving therapeutics for patients around the world.

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