Expert Pharmaceutical Compliance Specialist

2 weeks ago


Alleppey, Kerala, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Regulatory Affairs Professional

Location: Remote

Position Overview:

We are seeking an experienced regulatory affairs expert with expertise in pharmaceutical and medical device compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities.

Key Responsibilities:

  • Developed and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Maintained compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
  • Collaborated with regulatory authorities (FDA, EMA, CDSCO, MHRA) during product submissions, inspections, and audits.
  • Developed and implemented 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.


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