Regulatory Affairs Specialist - TJ / 1898485

Our client Nutrico Morinaga Pvt Ltd is looking for a Regulatory Affairs Specialist in Lahore

Nutrico Morinaga Pvt Ltd is seeking a detail-oriented Regulatory Affairs Executive to support the management of regulatory processes and ensure compliance with applicable laws and guidelines. The ideal candidate holds a Pharm-D degree and has at least three years of experience in regulatory affairs within the pharmaceutical or nutraceutical industry. This role is focused on preparing and submitting regulatory documentation, maintaining quality standards, and effectively interacting with health authorities to facilitate product registrations and approvals. The Regulatory Affairs Executive plays a key role in maintaining thorough documentation control and supporting the overall product lifecycle management while ensuring adherence to company and regulatory standards.

This position requires strong organizational skills and the ability to work independently, as it does not involve managing a team. The successful candidate will utilize regulatory submission software and document management systems to streamline processes, support quality assurance initiatives, and ensure timely and accurate submission management. By coordinating with internal departments and external regulatory bodies, the Regulatory Affairs Executive contributes to the efficient registration and ongoing compliance of products, supporting company growth and regulatory integrity.

Responsibilities

• Prepare, compile, and submit regulatory documents to health authorities in compliance with applicable regulations and company policies.
• Ensure that all product registrations are completed effectively and in a timely manner to maintain market authorization.
• Maintain and update regulatory submission tracking systems and document management platforms to ensure accurate and organized records.
• Interact professionally with health authorities, responding to queries and providing necessary documentation to facilitate approval processes.
• Support quality assurance by reviewing regulatory documentation for completeness, accuracy, and adherence to guidelines.
• Coordinate with cross-functional teams such as research and development, quality control, and manufacturing to gather required information for regulatory submissions.
• Monitor changes in regulatory requirements and update company procedures accordingly to ensure ongoing compliance.
• Assist in managing product lifecycle processes by maintaining up-to-date regulatory dossiers and supporting variations or amendments submissions.
• Use regulatory submission software effectively to prepare dossiers, manage timelines, and track submission statuses.
• Implement document control best practices to maintain confidentiality, traceability, and audit readiness of all regulatory files.
• Assist with internal and external audits related to regulatory affairs and support corrective actions if required.
• Provide regulatory guidance and support for new product development and existing product modifications within the regulatory framework.