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.
Job Description
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.
Why Join Unique Biotech?
✅ Work in a reputed biotech firm with a strong industry presence.
✅ Gain hands-on experience in global regulatory submissions.
✅ Collaborate with cross-functional teams in a dynamic environment.
✅ Opportunity to work on diverse regulatory portals (FSSAI, Sugam, ODLS).
