Elegant Cosmed Private Limited
Website:
elegantcosmed.com
Job details:
🏢 Company: ELEGANT COSMED PVT. LTD.
📍 Work Location: Plot No. 32 & 33 GIDC Kuvadava-360023, Rajkot
💼 Position: Regulatory Affairs Officer
⏳ Experience Required: 6-10 Years
🕘 Working Hours: 8:30 AM to 6:00 PM
Job Summary
We are seeking a focused and motivated Regulatory Affairs Officer – External Preparations with 2 to 3 years of hands-on experience in the pharmaceutical industry. In this role, you will be responsible for compiling, reviewing, and executing regulatory submissions for our semi-solid and liquid dosage portfolios (ointments, creams, gels, and lotions).
This is an operational role requiring a professional who can independently handle dossier compilation, query responses, and post-approval variations for domestic or international markets under the guidance of a senior manager.
Key Responsibilities
1. Dossier Compilation & Lifecycle Management
- Compile Module 3 (CMC) data for external preparations, ensuring precise documentation of manufacturing processes, active ingredients, and excipients.
- Prepare and format regulatory dossiers (such as eCTD or ACTD) for target markets under strict deadlines.
- Assist in drafting and filing post-approval variations and annual reports for routine manufacturing scale-ups or site changes.
2. Technical Evaluation & Compliance
- Review stability study reports specifically tracking physical parameters like viscosity, phase separation, and microbial limits of semi-solids.
- Check packaging documentation to ensure container closure systems (tubes, pumps, bottles) meet regulatory compliance.
- Cross-verify raw analytical data against pharmacopeial standards (USP, BP, IP) before submission.
3. Artwork & Query Resolution
- Coordinate the review and update of product labels, cartons, and Patient Information Leaflets (PIL) to match approved regulatory text.
- Draft preliminary responses to Health Authority queries and deficiency letters by gathering necessary data from R&D and Quality Control.
Job Requirements & Qualifications
- Education: Bachelor’s or Master’s degree in chemistry (MSc Chemistry), Pharmacy (B. Pharm / M. Pharm) or Pharmaceutical Sciences. A specialization or postgraduate diploma in Regulatory Affairs is highly preferred.
- Experience: 2 to 5 years of hands-on experience in Regulatory Affairs, with a proven track record explicitly supporting external preparation/semi-solid product lines.
- Core Knowledge: Deep familiarity with manufacturing variations for semi-solids (e.g., change in manufacturing site, scale-up changes under SUPAC-SS guidelines)
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