Regulatory Affairs Executive

Company: ELEGANT COSMED PVT. LTD.

Work Location: Plot No. 32 & 33 GIDC Kuvadava-360023, Rajkot

Position: Regulatory Affairs Executive

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 Executive – 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)