Regulatory Affairs Specialist

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 40,00,000 - ₹ 80,00,000
Job Opportunity:

The position of Regulatory Affairs Specialist is open for applications.

This role plays a vital part in ensuring compliance with international guidelines and country-specific requirements.

  • Key responsibilities include preparing, reviewing, and maintaining regulatory documents, coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Functional Skills Required:

  • A deep understanding 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.

This individual contributor role requires a graduate/postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline and 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.

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