• Application Deadline: Sun, 10 Dec 2023 00:00:00 GMT
• Position: Regulatory Affairs Manager


• Job Type Full Time


• Qualification BA/BSc/HND


• Experience 8 years


• Location Lagos


• Job Field Law / Legal 
  

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.