Deputy Head – Regulatory Affairs

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 companys 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 companys 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., TV, 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

1015 years in regulatory affairs with proven leadership exposure.

Reporting Structure

• Reports To: Head - Regulatory Affairs.
• Direct Reports: Regulatory Affairs Staff (46 members).
• Location: Madurai, India.