Product Registration Expert

8 hours ago

Thiruvananthapuram, Kerala, India beBeeCompliance Full time ₹ 16,00,000 - ₹ 24,50,000
Regulatory Compliance Specialist

The Regulatory Compliance Specialist plays a pivotal role in ensuring adherence to international regulations and country-specific requirements. This involves collaborating with internal teams and external stakeholders to facilitate product registrations, timely dossier submissions, query responses, and regulatory standards.

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.
  • 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.
  • Collaborate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.

This role requires strong analytical skills, attention to detail, and excellent organizational skills. The successful candidate will have a graduate/postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline, and 3–6 years of relevant experience in regulatory affairs.

Requirements:

  • Graduate/postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 3–6 years of relevant experience in regulatory affairs.

Benefits:

This role offers a unique opportunity to work in a dynamic environment and contribute to the success of our organization.

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