Senior Regulatory Compliance Professional

16 hours ago

Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 5,00,000 - ₹ 7,00,000
Regulatory Affairs Specialist

This role is responsible for preparing, reviewing and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.

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

  • A graduate or postgraduate degree in a relevant field such as pharmacy, life sciences, biotechnology or a related discipline is required.
  • 3-6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Excellent organizational, analytical and communication skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.

Key Responsibilities:

  • Screen and analyze documents received for product registration requests as per country-specific guidelines.
  • Prepare, compile and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents (e.g. DOC, COA) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines and processing payments/invoices.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to ensure consistency across product categories.
  • Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.

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.

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.

As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements and supporting business growth through effective regulatory strategies.

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