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Regulatory Compliance Expert

2 weeks ago

Manila, National Capital Region, Philippines Dr. Reddy's Laboratories Full time
About the Role

At Dr. Reddy's Laboratories, we are driven by a shared purpose to accelerate access to affordable and innovative medicines.

We have three core businesses: Global Generics, Pharmaceutical Services, and Active Ingredients and Proprietary Products.

Our global presence spans 56 countries, with a strong and growing Biologics portfolio and a rich, transnational R&D network.

Key Responsibilities
  • Prepare and submit regulatory dossiers for product registrations
  • Deliver registration goals with minimal supervision
  • Monitor and follow up on product filings for early approval of applications
  • Revise artworks, including prescribing information, to ensure regulatory compliance
  • Manage product lifecycles, including variations, renewals, and post-approval commitments
  • Participate in industry associations to stay updated on regulations
  • Create and revise SOPs to ensure quality standards
  • Manage quality activities, such as product release, complaint handling, deviations, change controls, self-inspections, trainings, documentations, and risk management
  • Oversee pharmacovigilance activities, including adverse event monitoring
  • Audit third-party distributors to ensure compliance
  • Support internal and external audits and implement corrective actions
  • Maintain good relationships with stakeholders internally and externally