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Deputy Head – Regulatory Affairs

Company

Aurolab

Location

madurai, tamil nadu

Type

Full-time

As we scale our manufacturing footprint including our expansion into the AMTZ and our new pharmaceutical facility the regulatory landscape is our most critical strategic pillar. We are seeking a Deputy Head of Regulatory Affairs to lead the complex task of harmonizing international standards across our proprietary brands and our OBL/White Label partnerships .


Key Result Areas (KRAs)

  • Market Access & Timelines: Achieve 100% on-time submission and approval of regulatory dossiers for new product launches.
  • Audit & Recall Readiness: Maintain a ‘Zero Critical Non-Conformance‘ status during audits and ensure the Global Recall System is ‘well-oiled‘ and capable of immediate execution.
  • Clinical & Scientific Authority: Oversee the successful completion of clinical trials data to support EU MDR <...

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