Regulatory Affairs Specialist

17 hours ago

Alwar, Rajasthan, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000
Regulatory Compliance Specialist

The primary objective of this position is to ensure compliance with international guidelines and country-specific requirements by preparing, reviewing, and maintaining regulatory documents.

This role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Responsibilities include:

  • Screening and analyzing documents received for product registration requests as per 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.

Required Skills and Qualifications:

  • Graduate/Postgraduate degree in a relevant field such as 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 Required:

  • 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 Required:

  • 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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