Syneos Health is hiring experienced Consultant / Senior Consultant professionals across PAN India for high-impact roles in CMC authoring and regulatory submissions.
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This is an excellent opportunity for professionals with strong expertise in Module 3 authoring, post-approval variations, and global regulatory compliance (EU + ROW markets).
🔍 Job Overview
- Role: Consultant / Senior Consultant – Regulatory Affairs (CMC Module 3)
- Location: PAN India
- Qualification: M.Pharm / Master’s in Life Sciences
- Experience: 3–10 years (preferred for senior roles)
- Employment Type: Full-Time
💼 Key Responsibilities
- Author and review CMC Module 3 dossiers for regulatory submissions
- Handle post-approval variations including site transfers, process changes, and specifications updates
- Ensure compliance with EU and ROW regulatory guidelines
- Work on API & Drug Product (DP) documentation and lifecycle management
- Perform gap analysis and ensure submission readiness
- Collaborate with cross-functional teams (QA, QC, Manufacturing, RA)
- Maintain compliance with ICH, EMA, and global regulatory standards
🎓 Qualifications & Skills
- M.Pharm / MSc Life Sciences (mandatory)
- Strong hands-on experience in CMC Module 3 authoring and review
- Exposure to API and Drug Product variations
- Knowledge of EU regulatory requirements and ROW markets
- Familiarity with eCTD submissions and regulatory lifecycle management
- Excellent documentation and communication skills
🌟 Benefits
- Opportunity to work with a leading global CRO like Syneos Health
- Exposure to global regulatory submissions (EU + ROW)
- Competitive salary and career growth opportunities
- Work on high-impact post-approval regulatory projects
- Collaborative and professional work environment
📩 How to Apply
Interested candidates can share their updated resume to:
📧Puja.khemchandani@syneoshealth.com
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