Regulatory Affairs Job

Unique Biotech is a leading name in the pharmaceutical and biotechnology industry, specializing in API and finished product registrations. With a strong reputation (3.5/5 from 72 reviews), the company is known for its commitment to regulatory compliance and innovation in drug development. Key Responsibilities: Prepare, review, and submit technical documents (CTD/ACTD) for regulatory and non-regulatory markets. Conduct gap analysis of dossiers and address discrepancies before submission to MOH. Handle customer and Ministry of Health (MOH) queries efficiently. Coordinate with cross-functional teams and review documents (Specifications, MOA, Analytical Method Validations, BMR, BPR, etc.). Manage post-approval variations and re-registration (renewal) procedures. Work with online portals like ODLS, FSSAI, and Sugam for drug and food product licensing. Maintain registration information management systems. Ensure compliance with EAEU, ICH, and EMEA guidelines. Required Skills & Qualifications: Education: Bachelor's/Master's in Biotechnology, Microbiology, Pharmacy, or Regulatory Affairs. Experience: 1-4 years in Regulatory Affairs within the pharmaceutical industry. Strong knowledge of API & Finished Product Registration guidelines. Proficiency in handling regulatory submissions, variations, and renewals. Excellent interpersonal, communication, and organizational skills.

Unique Biotech is a leading name in the pharmaceutical and biotechnology industry, specializing in API and finished product registrations. With a strong reputation (3.5/5 from 72 reviews), the company is known for its commitment to regulatory compliance and innovation in drug development.