Regulatory Affairs Officer Job at BioMatrix Healthcare, Apply Now!
Looking for a rewarding career in regulatory affairs? BioMatrix Healthcare Pvt. Ltd., a leading export-oriented pharmaceutical company, is hiring a Regulatory Affairs Officer/Senior Officer in Ahmedabad, India. This role is crucial in ensuring regulatory compliance, dossier preparation, and expanding our global market reach. If you have a B.Pharm/M.Pharm degree and experience in ROW Market regulatory requirements, apply now to be part of a company committed to “Supporting Life Worldwide. With more than 850 product registrations, we are expanding into 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 a strong understanding of market specifics and regulatory requirements (Mandatory skill).
Job Location
Sindhu Bhavan Road, Thaltej, Ahmedabad.
Roles and Responsibilities for Regulatory Affairs Officer Job:
- 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 as Regulatory Affairs Office.
- 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.
Keywords: Regulatory Affairs Officer, Sr. Officer, BioMatrix Healthcare, Pharmaceutical, ROW Market, Dossiers, BE Report
