Global Regulatory Affairs Specialist

1 week ago

Kollam, Kerala, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000
Job Description:

The key objective of this Regulatory Affairs Professional is to prepare, review and maintain regulatory documents ensuring compliance with international guidelines and country-specific requirements.

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

Key responsibilities include screening analyzing documents preparing compiling reviewing product dossiers prioritizing dossiers for timely submission drafting coordinating responses to regulatory queries and managing legalization of registration documents.

">Required Skills and Qualifications:
  • Strong understanding of global regulatory guidelines
  • Dossier preparation and detail-oriented skills
  • Excellent organizational analytical skills and proficiency in MS Office and document management systems
  • 3-6 years of relevant experience in regulatory affairs preferably in pharmaceuticals biotechnology or healthcare
">Benefits:

This individual contributor role reports to the Assistant Manager - RA and handles a team size effectively under pressure meeting strict deadlines.

Desired candidate has strong attention to detail ability to work effectively under pressure team player collaboration coordination skills proactivity adaptability willingness to take initiative professional communication interpersonal skills and proactive customer service.

">Others:

Functional skills required include knowledge of international regulatory requirements expertise in dossier compilation review and submission processes ability to prepare and analyze technical compliance-related documentation and familiarity with audit documentation and regulatory query management.

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