Job Description

Job Title: Regulatory Affairs Officer / Sr. Officer
Job Location: Ahmedabad, Gujarat, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Skills:
ROW Market, Prepare Dossiers, Guideline Knowledge, BE Report, AMV, BMR-BPR,
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
BioMatrix Healthcare is seeking a motivated Regulatory Affairs Officer/Senior Officer to join our team in Ahmedabad. This full-time, mid-level position requires a minimum of one year of experience and is pivotal in ensuring the compliance and registration of our pharmaceutical products. The successful candidate will play a key role in our regulatory submissions and expansion efforts within the ROW Market and beyond.
Qualifications And Skills
M.Pharm / B.Pharm

• Proficient in ROW Market with strong understanding of market specifics and regulatory requirements (Mandatory skill).

Job Location
Sindhubhavan Road, Thaltej, Ahmedabad.
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 the 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.
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