Global Regulatory Compliance Specialist

2 days ago

Vijayawada, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Regulatory Affairs Expert

Location: Remote

Position Overview:

We seek an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). A strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization is required.

Key Responsibilities:
  • Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interact with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
  • Develop and maintain regulatory strategies to support new product development and lifecycle management.
  • Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Assist in responding to regulatory queries, deficiency letters, and inspection findings.
  • Manage regulatory documentation archives and maintain compliance records for audits and inspections.

This role offers a unique opportunity to leverage your expertise in regulatory affairs and make a significant impact on our organization's success.

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