Pharma Regulatory Affairs Officer Job, Apply Online at BioMatrix Healthcare
BioMatrix Healthcare Pvt. Ltd. – Regulatory Affairs Officer / Sr. Officer
Location: Ahmedabad, Gujarat, India
Company Overview
BioMatrix Healthcare Private Limited, a leading export-oriented pharmaceutical company, is headquartered in Ahmedabad, Gujarat, India. Established in 2007, we are committed to “Supporting Life Worldwide” through our cutting-edge R&D and manufacturing processes. Accredited by WHO-GMP, we have a robust presence in over 30 countries, focusing on oral solids, liquids, and dry syrups. With over 850 product registrations, we are expanding our footprint in Europe, Latin America, and Southeast Asia.
Job Overview
Job Title: Regulatory Affairs Officer / Senior Officer
Job Location: Sindhubhavan Road, Thaltej, Ahmedabad
Qualifications And Skills
Qualification: M.Pharm / B.Pharm
Skills: Proficient in ROW Market with strong understanding of market specifics and regulatory requirements
Roles And Responsibilities
- Prepare Dossiers for different countries
- Evaluation, Verification & Proper Checking of DMF (Drug Master File) of API
- Checking of Bioequivalence Study Report (BE Report), Analytical Method Validation (AMV)
- Technical documents review
- Checking of leaflets
- Prepare Documents for queries of individual countries
- Checking of Documents for COPP, Product Permission, LL Application as per requirement
- Review of technical documents like BMR, BPR, Specifications, Label claim etc for different dosage forms
- Preparation of Leaflets
- Check Samples against Registration Documents for Physical Parameters
- Prepare & review Documents for queries of individual countries
- Review Documents before compilation of Dossiers
Desired Skills and Experience
ROW Market, Prepare Dossiers, Guideline Knowledge, BE Report, AMV, BMR-BPR
Link to Apply: APPLY ONLINE HERE
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