Senior Regulatory Compliance Expert

18 hours ago

Jodhpur, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 60,00,000 - ₹ 1,20,00,000

Regulatory Affairs Professional Needed

About the Role:

We are seeking a seasoned Regulatory Affairs professional with expertise in pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring adherence to applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).

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

Requirements:

  • Education and Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or a related field. Advanced degree preferred.
  • Experience and Skills: Minimum 5 years of experience in regulatory affairs, with expertise in pharmaceutical and medical device regulatory compliance.
  • Professional Certifications: Certified Regulatory Affairs Specialist (CRAS) or Certified Associate in Regulatory Affairs (CARA) certification preferred.

Benefits:

  • Opportunity to work in a dynamic environment
  • Competitive salary and benefits package
  • Professional growth and development opportunities

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