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Regulatory Affairs Specialist
Healthcare Medical
💰 Salary Not shared
📊 Market ₹25,000–₹45,000/mo (₹300,000–₹540,000/yr)
About the Company
Job Title: Regulatory Affairs Executive - Pharma Export (WHO-GMP / CDSCO) Location: Raipur, Chhattisgarh (based close to our manufacturing facility)
About the Role
We're hiring a Regulatory Affairs Executive to support our export drug registration process - working under our Head of Regulatory Affairs on CTD/ACTD dossier compilation, CDSCO documentation, and registration tracking across our active and target export markets. Being based at the plant means you're working directly with QA/QC and production to pull the data you need, rather than waiting on it over email. This is a hands-on, learning-focused role - you'll be building real regulatory experience from day one, with senior support to guide you as you grow into bigger responsibilities.
Responsibilities
- ● Support CTD/ACTD dossier compilation and documentation for export registration
- ● Assist with CDSCO-related paperwork - WHO-GMP certification, COPP applications, export NOCs
- ● Track registration status across our export markets (Africa, Middle East, CIS, South-East Asia) and flag what's pending
- ● Coordinate with QA/QC and plant teams to pull stability data, batch records, and COAs needed for submissions
- ● Maintain organized, submission-ready documentation under the Head of RA's review
- ● Learn the end-to-end registration process by working closely with senior RA and plant leadership
- ● 0-4 years of experience in pharmaceutical regulatory affairs, quality, or a related pharma function (freshers with a strong academic background are welcome to apply)
- ● B.Pharm / M.Pharm or equivalent
- ● Basic familiarity with CTD/ACTD documentation or willingness to learn quickly
- ● Comfortable working from Raipur, close to the manufacturing site
- ● Detail-oriented, organized, and reliable with documentation and deadlines
- ● Real, hands-on regulatory experience at a WHO-GMP certified export manufacturer - not a back-office desk job
- ● Being on-site at the plant means faster learning: direct access to QA/QC, production, and batch data instead of working at a distance
- ● Clear growth path into more senior regulatory responsibility as you prove yourself
Requirements
- ● Employment Type: Full-time, on-site
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