Regulatory Affairs CMC Coordinator Hiring for B Pharm, M Pharm, Biotech, Biochem Graduates
Regulatory Affairs CMC Coordinator Job Hyderabad
Apply for RA CMC Submission Coordinator at Novartis in Hyderabad. Openings for B.Pharm, M.Pharm, BSc, MSc, Biotech, and Biochemistry graduates. 1-2 years experience preferred.
Opportunity for Life Sciences Graduates at Novartis – RA CMC Submission Coordinator Role in Hyderabad
Novartis, a global leader in pharmaceuticals and innovation, is currently hiring for the position of RA CMC Submission Coordinator at its Hyderabad site. This full-time role is ideal for candidates with a background in Pharmacy, Biotechnology, Biochemistry, Chemistry, or Life Sciences, looking to build a career in Regulatory Affairs and Clinical Research.
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About the Role: RA CMC Submission Coordinator
As an RA CMC Submission Coordinator, you will support regulatory affairs activities, focusing on CMC (Chemistry, Manufacturing, and Controls) submission coordination, compliance documentation, and regulatory operations. Your contributions will be critical to timely clinical trial approvals, global registrations, and pharmaceutical product lifecycle maintenance.
Key Responsibilities
- Execute QC checks and compliance tasks including Document Archiving (DA), IND annual reports
- Prepare metadata forms, RA request forms, and maintain regulatory database entries.
- Format documents to ensure eCTD (electronic Common Technical Document) compliance
- Coordinate submission content and ancillary documentation with internal team.s
- Collaborate with global project teams and ensure KPIs are consistently met
- Support RA documentation systems and act as a super-user for specific regulatory platforms
- Ensure accuracy of submission-related certificates and licenses in the Document Management System
Who Can Apply?
Required Educational Background
- Minimum: General qualification for university entrance or completed vocational training
- Preferred: Degree in Pharmacy, Chemistry, Biochemistry, Biotechnology, Biology, or other Life Sciences disciplines
Experience Required
- Fresh graduates with a Science degree are welcome
- Candidates with 1-2 years of experience in regulatory affairs, pharma operations, or data systems will be preferred.
Desired Skills
- Strong understanding of pharmaceutical regulatory requirements
- Knowledge of GMP, eCTD guidelines, and clinical research documentation
- Excellent communication, analytical, and document formatting skills
- Comfortable working in global, cross-functional teams
How to Apply?
Interested candidates can apply directly through the official Novartis career portal.
Don’t miss this opportunity to start or grow your career in Regulatory Affairs at one of the top pharma employers in India.
Courses Covered Under Eligible Educational Background
- Pharmacy: B.Pharm, M.Pharm (Pharmaceutics, Pharmacology, Regulatory Affairs)
- Biotechnology: B.Sc Biotech, M.Sc Biotech, Genetic Engineering
- Biochemistry: B.Sc Biochemistry, M.Sc Biochemistry
- Chemistry: B.Sc Chemistry, M.Sc Organic Chemistry
- Life Sciences: B.Sc/M.Sc in Life Sciences, Microbiology, Molecular Biology
Quick Job Summary
| Company Name | Current Vacancies in Departments | Required Education | Experience Required |
|---|---|---|---|
| Novartis Healthcare | Regulatory Affairs – CMC | B.Pharm, M.Pharm, BSc/MSc in Biotech, Biochem | 0-2 Years |