Regulatory Affairs Manager at UNOCASA Limited

UnoCasa Limited is a full service Human Resources Consultancy business with focus on Talent Acquisition, Learning & Development and Consultancy services. Our raison d’etre is the notion that your people are your advantage and proffer people-centric solutions to ensure your team accomplish your business goals. We are not your run of the mill HR Company, we believe in team diversity and teamwork; we believe that the workplace should have an ambience that inspires productivity of the team; and the application of technologies to enhance efficiency. We know that every business is unique and tailor HR solutions to your organisation’s needs.

We are recruiting on behalf of our client to fill the position below:

Job Title: Regulatory Affairs Manager

Location: Lagos
Employment Type: Full-time

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.

Application Closing Date
11th December, 2023.