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
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- 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.
Deadline: December 11, 2023
Job Features
Job Category | Regulatory Affairs Manager |