Senior Regulatory Affairs Specialist

2 days ago

Anantapur, Andhra Pradesh, India beBeeRegulatoryAffairsExecutive Full time ₹ 60,00,000 - ₹ 1,00,00,000

Key responsibilities include preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements. Coordination with internal teams and external stakeholders is necessary to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Qualifications and skills

  • Graduate/Postgraduate in a relevant discipline such as Pharmacy, Life Sciences, or Biotechnology.
  • 3–6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.

Responsibilities

  1. Screen and analyze documents received for product registration requests as per country-specific guidelines.
  2. Prepare and review product dossiers in compliance with customer and regulatory requirements.
  3. Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  4. Respond to regulatory queries with appropriate documentation and justifications.
  5. Manage legalization or apostillation of registration documents, including coordination with agencies and tracking timelines.
  6. Support the Compliance team by providing updated documents required for technical file preparation.
  7. Review and update Technical Master Files to ensure consistency across product categories.
  8. Collaborate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements.

Required skills

  • Knowledge of international regulatory requirements.
  • Expertise in dossier compilation and submission processes.
  • Ability to prepare and analyze technical documentation.
  • Document management and record-keeping skills.

Behavioral skills

  • Attention to detail and accuracy.
  • Ability to work effectively under pressure and meet deadlines.
  • Collaboration and coordination skills.
  • Proactive and adaptable.

RegulatoryAffairsExecutive

Reporting to: Assistant Manager - Regulatory Affairs

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