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Regulatory Affairs Specialist

Regulatory Affairs Specialist

beBeeRegulatoryAhmedabad, Gujarat, India
16 hours ago
Job description

Job Title :

Regulatory Affairs Specialist

The primary responsibility of this role is to ensure compliance with international guidelines and country-specific regulations by preparing, reviewing, and maintaining regulatory documents.

About This Role :

This position involves collaboration with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and adherence to regulatory standards.

Required Skills and Qualifications :

  • A graduate or postgraduate degree in pharmacy, life sciences, biotechnology, or a related field.
  • 3–6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.

Responsibilities :

  • Screening and analyzing documents received for product registration requests according to country-specific guidelines.
  • Preparing, compiling, and reviewing product dossiers in compliance with customer and regulatory requirements.
  • Prioritizing dossiers to meet defined timelines and ensuring timely submission to the regulatory authorities.
  • Drafting and coordinating responses to regulatory queries with appropriate documentation and justifications.
  • Arranging supportive batch-related documents for registration samples.
  • Managing legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments / invoices.
  • About the Position :

    This role offers an exciting opportunity to work in a dynamic environment where you will be responsible for ensuring the accuracy and completeness of regulatory documents.

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    Regulatory Specialist • Ahmedabad, Gujarat, India

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