Regulatory Affairs Specialist

“Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.”

Responsibilities:

• Coordinate the preparation and submission of regulatory documents for Parkville’s products, ensuring compliance with relevant standards.
• Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly.
• Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases.
• Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs).
• Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication.
• Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible.
• Develop and review product leaflets (SPC & PIL) and submit them to the appropriate regulatory authorities for approval.
• Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies. of Health / CAPA.

Requirements:

Education:

Bachelor’s degree from reputable university Degree in Pharmacy, Veterinary Medicine, Science is an advantage.

Experience:

Previous experience in pharmaceuticals industry from 3-4 years in the same position, responsibilities.