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A leading global CRO is hiring a Regulatory Associate (EU Market, CMC Module 3) for its Clinical Solutions team. This remote regulatory affairs job in India is ideal for candidates with 0.5โ2 years of experience in CMC (Chemistry, Manufacturing & Controls), especially in small molecule regulatory submissions.
This opportunity offers exposure to EU regulatory markets, IND/NDA/MAA submissions, and lifecycle management, making it highly valuable for early-career professionals in regulatory affairs and pharmaceutical development.
๐ข About the Company
Syneos Health is a global, fully integrated biopharmaceutical solutions organization supporting drug development and commercialization. The company has contributed to a majority of recent FDA and EMA approvals.
๐ Key Responsibilities
- Assist in preparing regulatory submission documents (INDs, NDAs, MAAs, DMFs)
- Support CMC Module 3 documentation for small molecules
- Conduct gap analysis and regulatory research
- Handle variations, renewals, and lifecycle management activities
- Perform quality checks on regulatory documents
- Support orphan drug designation requests
- Compile and analyze regulatory data for reporting
- Collaborate with cross-functional teams
๐ Qualifications & Skills
- Degree in Pharmacy / Life Sciences / Regulatory Affairs
- 0.5 to 2 years experience (internship accepted)
- Knowledge of EU regulatory guidelines and CMC documentation
- Exposure to EU, GCC, or APAC markets (preferred)
- Strong analytical and communication skills
- Proficiency in Microsoft Office tools
- Ability to manage multiple projects and deadlines
๐ผ Benefits & Work Environment
- 100% Remote / Hybrid flexibility
- Strong career development and training programs
- Exposure to global regulatory submissions
- Inclusive and collaborative work culture
- Opportunity to work on innovative drug development projects
๐ Job Location
- Remote (India)
- Hybrid option: Gurugram
๐ฐ Salary Insight (India)
- Estimated Range: โน4,00,000 โ โน8,00,000 per annum
(Based on industry benchmarks for Regulatory Associate roles with 0โ2 years experience)
๐ฉ How to Apply
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