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Junior Manager – Regulatory Affairs | Syngene International Limited
Syngene International Limited
Junior Manager – Regulatory Affairs | Syngene International Limited
Job Title: Junior Manager – Regulatory Affairs
Location: Syngene International Limited, Biocon SEZ, Biocon Park, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India
About Syngene
Syngene International (www.syngeneintl.com) is an innovation-driven contract research, development, and manufacturing organization offering fully integrated scientific services – from early discovery to commercial supply. We work with leading global pharmaceutical, biotechnology, and healthcare companies, enabling them to advance new therapies that address unmet medical needs.
At Syngene, safety and quality are at the heart of everything we do. Our culture emphasizes accountability, compliance, and the highest ethical standards while maintaining a healthy, collaborative workplace.
Role Overview
We are seeking a Junior Manager – Regulatory Affairs with expertise in CMC regulatory affairs, eCTD filing, and lifecycle management. The role requires close collaboration with internal teams and clients to ensure successful filings, product registrations, and post-approval maintenance across developed and emerging markets.
Key Responsibilities
- Provide CMC regulatory support throughout the drug development cycle for small molecules, biologics, and generics.
- Lead and manage eCTD filings, regulatory document management systems (RDMS/EDMS), and QMS activities.
- Research regulatory requirements for new molecules/categories and deliver feasibility and technical inputs.
- Review plant and R&D documentation (BMR, BPR, method validation, process validation, specifications, development reports, etc.) for compliance.
- Identify regulatory requirements for IND, NDA, MAA, ANDA, ANADA, and other dossiers; prepare checklists and ensure submission compliance.
- Author, compile, and publish regulatory dossiers in a timely manner, including responses to agency queries.
- Contribute to regulatory strategy development and provide guidance to stakeholders and clients.
- Manage renewals and lifecycle updates of product dossiers/DMFs.
- Oversee regulatory project management activities.
- Review and maintain quality agreements and compliance trackers.
- Mentor and train staff on regulatory policies and SOPs.
Required Skills & Experience
- Experience: 6–13 years in CMC Regulatory Affairs for APIs and formulations (preferably injectables) targeting the US, EU, and developed markets.
- Hands-on experience with eCTD submissions and familiarity with RDMS, EDMS, and QMS systems.
- Strong understanding of CMC (API & Drug Product) regulatory requirements.
- Prior exposure to investigational medicinal products and marketing authorizations.
- Additional experience with biologicals, ADCs, or veterinary drugs is a plus.
Education
- B.Pharm / M.Pharm / Life Sciences degree.
- Minimum of 5+ years of pharmaceutical or life sciences industry experience.
Leadership & Values
All Syngene employees are expected to uphold our values of:
- Excellence
- Integrity
- Professionalism
Equal Opportunity Employer
Syngene is committed to providing equal employment opportunities regardless of age, gender, ethnicity, disability, or background. We also provide reasonable accommodations for qualified individuals with disabilities.
Why Join Syngene?
- Opportunity to contribute to life-changing therapies impacting global healthcare.
- Work in a world-class research and manufacturing environment.
- Career growth through continuous learning and development.
- Culture that prioritizes safety, quality, and integrity.
How to Apply
Apply directly through the official Syngene careers portal: Apply Here
Quick Job Summary Table
| Position | Junior Manager – Regulatory Affairs |
|---|---|
| Company | Syngene International Limited |
| Location | Bengaluru, Karnataka, India |
| Experience | 6–13 years (CMC Regulatory Affairs) |
| Education | B.Pharm / M.Pharm / Life Sciences |
| Key Skills | CMC, eCTD, Regulatory Strategy, QMS |
| Apply Link | Click Here |
FAQs
Q1: What type of products will I work on?
Small molecules, biologics, generics, and investigational medicinal products for developed and emerging markets.
Q2: Is prior experience in eCTD filing mandatory?
Yes, hands-on eCTD experience is essential for this role.
Q3: What markets does this role primarily cover?
US, EU, and other developed markets, with some support for emerging countries.
Q4: Does the role involve people management?
Yes, mentoring and training junior staff is part of the responsibilities.
Q5: Are biologicals and ADC regulatory experience necessary?
Not mandatory but highly desirable.
To apply for this job please visit careers.syngeneintl.com.