Senior Regulatory Compliance Officer

4 hours ago

Bareilly, Uttar Pradesh, India beBeeRegulatory Full time ₹ 10,51,200 - ₹ 14,21,600
Regulatory Affairs Specialist

This position involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements. The Regulatory Affairs Executive will coordinate with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

The RA Specialist role encompasses several key responsibilities including:

  • Screening and analyzing documents 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.
  • Supporting the Compliance team by providing updated documents required for technical file preparation.
  • Periodically reviewing and updating Technical Master Files to ensure consistency across product categories.
  • Coordinating with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensuring timely preparation and submission of documents related to audit findings.

Qualifications and Skills Required

  • Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 3-6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Detail-oriented, with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Good written and verbal communication skills.

Functional Skills

  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.

Behavioral Skills

  • Strong attention to detail and accuracy.
  • Ability to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.
  • Professional communication and interpersonal skills.

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