Regulatory Affairs Career Opportunity

1 week ago


Mysore, Karnataka, India beBeeCompliance Full time ₹ 60,00,000 - ₹ 1,20,00,000
Regulatory Affairs Professional

The primary objective of this role is to prepare, review, and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.

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

  • Preparation and analysis of regulatory documents in compliance with customer and regulatory requirements.
  • Prioritization of dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Drafting and coordinating responses to regulatory queries with appropriate documentation and justifications.

This role requires strong attention to detail, excellent organizational and analytical skills, and proficiency in MS Office and document management systems.

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, is also essential.

  • 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.

This is an individual contributor role reporting to the Assistant Manager - Regulatory Affairs.



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