Regulatory Affairs Executive - TJ / 1898485

Our client, Nutrico Morinaga Pvt Ltd, is seeking a Regulatory Affairs Executive based in Lahore. The ideal candidate will be responsible for managing regulatory processes to ensure compliance with relevant laws and guidelines within the pharmaceutical or nutraceutical sectors. This role requires a detail-oriented professional with a Pharm-D degree and a minimum of three years’ experience in regulatory affairs. The position focuses on preparing and submitting regulatory documentation, maintaining quality standards, and liaising with health authorities to facilitate product registrations and approvals. The Regulatory Affairs Executive will play a crucial role in documentation control and product lifecycle management, ensuring adherence to both company policies and regulatory requirements.

Key Responsibilities

- Prepare, compile, and submit regulatory documents to health authorities in accordance with applicable regulations and company policies.
- Ensure timely and effective completion of product registrations to maintain market authorization.
- Maintain and update regulatory submission tracking systems and document management platforms to keep accurate and organized records.
- Professionally interact with health authorities by responding to queries and providing necessary documentation to support approval processes.
- Support quality assurance by reviewing regulatory documentation for completeness, accuracy, and compliance with guidelines.
- Coordinate with cross-functional teams including research and development, quality control, and manufacturing to gather information required for regulatory submissions.
- Monitor changes in regulatory requirements and update company procedures to ensure ongoing compliance.
- Assist in managing product lifecycle processes by maintaining up-to-date regulatory dossiers and supporting submissions for variations or amendments.
- Utilize regulatory submission software to prepare dossiers, manage timelines, and track submission statuses efficiently.
- 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 when necessary.
- Provide regulatory guidance and support for new product development and modifications of existing products within the regulatory framework.

Required Qualifications

- Pharm-D degree is mandatory.
- Minimum of three years of experience in regulatory affairs within the pharmaceutical or nutraceutical industry.
- Strong organizational skills with the ability to work independently.
- Proficiency in regulatory submission software and document management systems.
- Excellent communication skills for effective interaction with health authorities and internal teams.
- In-depth knowledge of regulatory requirements and guidelines relevant to product registration and compliance.

Preferred Qualifications and Benefits

While specific benefits are not detailed, candidates with experience in quality assurance initiatives, product lifecycle management, and audit support will be highly valued. The role offers an opportunity to contribute significantly to the company’s regulatory integrity and growth by ensuring efficient registration and ongoing compliance of products.

This position does not involve team management but requires a proactive approach to regulatory affairs and strong collaboration with various departments to achieve organizational goals.