Regulatory Affairs Expert

2 days ago

Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000

Ensure regulatory compliance and drive product development with our team.

Job Overview

The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

  • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.

You will work closely with cross-functional teams to ensure that all regulatory requirements are met, and our products are developed and launched on time.

Requirements
  • Proven experience in regulatory affairs, preferably in the pharmaceutical or medical device industry.
  • Strong understanding of regulatory requirements, including FDA, EMA, CDSCO, MHRA, ISO 13485, and ICH guidelines.
  • Excellent communication and interpersonal skills, with the ability to interact with regulatory authorities and internal stakeholders.
  • Ability to analyze complex regulatory information and develop effective solutions.
  • Strong problem-solving skills, with the ability to resolve regulatory issues promptly.

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