Regulatory Affairs Specialist

6 days ago


Ahmedabad, Gujarat, India Lifelancer Full time

About the Role

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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.

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Job Overview

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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.

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Key Responsibilities

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  • 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.">
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Requirements

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To be successful in this role, you will need:

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  • 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.">
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What We Offer

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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.

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Location

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The role is based in Ahmedabad, Gujarat, India.

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About Us

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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.

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Contact Information

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For more information, please visit our website at Lifelancer.com



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