Regulatory Affairs Manager at UNOCASA Limited

Description

• Our client, a pharmaceutical company is dedicated to excellence and compliance, is seeking a Regulatory Affairs Manager to ensure the company’s adherence to regulatory standards, particularly those set by NAFDAC and the Pharmacist Council of Nigeria.

Key Responsibilities

• Maintain the company’s current registration with the Pharmacist Council of Nigeria.
• Lead the preparation and submission of regulatory agency applications, reports, and correspondence.
• Develop and execute regulatory strategies for new product submissions and renewals.
• Respond to regulatory agencies regarding product information and issues.
• Ensure the timeliness, accuracy, and compliance of all regulatory agency submission materials.
• Verify that detailing materials, information leaflets, and packaging artworks meet regulatory requirements.
• Communicate regulatory issues to management and stakeholders and develop appropriate responses.
• Collaborate with all company departments to secure relevant permits and certificates.
• Manage activities such as audits, regulatory agency inspections, and product recalls.
• Coordinate the disposal of expired and rejected products and materials.
• Participate in the development and implementation of clinical trial protocols.
• Provide regulatory guidance to departments and development project teams.
• Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
• Represent the company in relevant Trade association meetings, including NIROPHARM and PMGMAN.
• Perform any other duties delegated by the line manager.

Requirements

• Interested candidates should possess a Bacheor's Degree in relevant fields with a minimum of 8 years work experience.