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
Standard Core Responsibilities
- Strategic Leadership: Define and execute the company's regulatory vision and strategy, ensuring alignment with global and local requirements.
- Product Registration: Oversee the full lifecycle management, registrations, and approvals for all product lines.
- Regulatory Compliance: Maintain strict adherence to laws and industry standards including FDA, EU (MDR/GMP), and CDSCO.
- QMS Safeguarding: Oversee and safeguard the company's Quality Management System (QMS).
- Cross-Functional Collaboration: Work closely with R&D, manufacturing, and quality assurance to support new product development with regulatory guidance.
Audit, Clinical & OBL Scope
- Audit Leadership & Notified Bodies: Act as the primary point of contact and front-face for Notified Bodies (e.g., TÜV, BSI) and National Authorities (CDSCO, FDA). Lead the organization through rigorous international audits with a focus on technical file reviews and facility inspections.
- OBL & White Label Management: Manage the regulatory approvals and compliance certifications for products manufactured by Aurolab but sold under partner brands.
- Recall & Vigilance System: Manage a well-oiled product recall system and lead the end-to-end process of field safety corrective actions (FSCA).
Candidate Profile: Technical Command & Standards
The successful candidate must demonstrate an expert command over the following critical standards:
Category & Specific Requirements
Audit Experience
Proven track record of successfully facing and clearing International Audits (US FDA, EU MDR) and National Audits (CDSCO/State Licensing).
Agency Acquaintance
Established acquaintance with Notified Bodies and a deep understanding of their expectations regarding technical documentation and QMS.
QMS & Risk
Mastery of ISO 13485, EU GMP, and ISO 14971 (Risk Management) across the product lifecycle.
Facility & Process
Deep understanding of Cleanroom Classifications (ISO 14644), Sterilization Validation, and Aseptic Filling protocols.
Qualification
Expert knowledge of Facility Qualification (IQ/OQ/PQ) and Process Validation for high-precision manufacturing.
Experience
10–15 years in regulatory affairs with proven leadership exposure.
Reporting Structure
- Reports To: Head - Regulatory Affairs.
- Direct Reports: Regulatory Affairs Staff (4–6 members).
- Location: Madurai, India.
