Opportunity Description
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 requirements.
Partner Compliance: Ensure all OBL/White Label technical files meet the stringent requirements of international partner companies.
Core Responsibilities & Technical Scope
Stand...
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 requirements.
Partner Compliance: Ensure all OBL/White Label technical files meet the stringent requirements of international partner companies.
Core Responsibilities & Technical Scope
Stand...
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