UnoCasa Limited was incorporated in 2009 to provide companies with business solutions in Marketing, Business Strategy , Recruitment and general Human Resources consultancy.
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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.
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