Regulatory Affairs Specialist
6 days ago
About the Role
">We are seeking a highly skilled 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.
">Job Overview
">BioMatrix Healthcare is expanding its presence in over 30 countries, focusing on oral solids, liquids, and dry syrups. With over 850 product registrations, we are looking for a motivated individual to play a key role in our regulatory submissions and expansion efforts within the ROW Market and beyond.
">Key Responsibilities
">- ">
- Prepare Dossiers for different countries to ensure compliance with regulatory requirements.">
- Evaluate, verify, and check DMF (Drug Master File) of API, Bioequivalence Study Report (BE Report), Analytical Method Validation (AMV), and other technical documents.">
- Review and prepare documents for queries from individual countries.">
- Check samples against registration documents for physical parameters.">
- Prepare and review documents before compilation of Dossiers.">
Requirements
">To be successful in this role, you will need:
">- ">
- M.Pharm / B.Pharm degree.">
- Proficient in ROW Market with strong understanding of market specifics and regulatory requirements.">
- Excellent communication and organizational skills.">
- Ability to work in a fast-paced environment.">
- Strong attention to detail and analytical skills.">
What We Offer
">BioMatrix Healthcare offers a competitive salary of ₹8,00,000 - ₹12,00,000 per annum, depending on experience, plus benefits including health insurance, retirement plan, and opportunities for career growth.
">Location
">The role is based in Ahmedabad, Gujarat, India.
">About Us
">BioMatrix Healthcare Private Limited is a leading export-oriented pharmaceutical company headquartered in Ahmedabad, Gujarat, India. Established in 2007, we are committed to 'Supporting Life Worldwide' through our cutting-edge R&D and manufacturing processes.
">Contact Information
">For more information, please visit our website at Lifelancer.com
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