A Regulatory Affairs Manager is responsible for the regulatory affairs activity of the organization. He/ She will be responsible for coordinating all regulatory activities with the regulatory bodies with respect to factory and product registration. He/ She will be responsible for corresponding with various principals on regulatory and compliance activities, registration processes and margin improvement of existing registered products. He/ She must be responsible for all required regulatory activities as required by internal stakeholders.
The Regulatory Affairs Manager will ensure compliance with regulatory bodies and provide regulatory support as required in various activities.
Responsibilities
Ensure compliance with regulatory bodies such as SON & NAFDAC
Development of regulatory strategies prior to approval and also after the approval of a new product.
Provide Regulatory support as required in the evaluation of Consumer complaints.
Provide regulatory guidance as related to product marketing and advertisement.
Document and file all proceedings and meetings between company and Regulatory bodies.
Keep abreast of related regulations and provide updates as needed regarding regulatory status and requirements.
Ensuring regulatory compliance of all registered products.
Ensuring that company standards are in line with NAFDAC & SON requirements.
Ensuring that company complies with NAFDAC Codex guidelines concerning food additives, nutrition and also proper labeling of products.
Representing the company in meetings with regulatory authorities such as: NAFDAC & SON.
Registration of locally manufactured food & cosmetics Products.
Registration of imported food, cosmetics, medical devices.
Renewal of expiring product registration license.
Processing of margin improvements for registered products such as: pack size extension, change in formulation, change in label design, change /additional packaging material, additional/ change in manufacturing source etc.
Coordination and execution of NAFDAC & SON Inspection of production facilities.
Coordination and execution of destruction exercises for expired or damaged products.
Processing of all material importation permit.
Processing and registration of global listing for supermarket items (GLSI) for food and cosmetics products.
Coordinating NAFDAC stamping of shipping documents for timely clearance of consignments.
Preparing weekly and monthly regulatory reports.
Frequent verification of NAFDAC Certificates validity.
Maintenance of NAFDAC Master File.
Provide Regulatory support as required in registration and by the Form M & clearing team.
Coordinate all MAN (Manufacturers Association of Nigeria) registration for factories.
Coordinate all Factory registration processes.
Product Registration: Compile, review, and submit technical dossiers for new and existing product registrations.
Liaison Management: Maintain professional communication with NAFDAC & SON officials to expedite approvals and resolve queries.
Facility Inspections: Coordinate and host NAFDAC & SON inspectors during audits of warehouses, factories, and production lines.
Qualifications
Minimum of 7 years' experience in regulatory affairs;
Experience working in a FMCG/FOOD environment where understanding of Food and FMCG manufacturing processes, marketing and advertisement requirements and the steps necessary to achieve effective GMP and audit results is required;
Demonstrated experience in managing regulatory projects;
Minimum of a Bachelor's degree in sciences preferred
Required Skills
Excellent interpersonal, and communication (oral and written);
Excellent presentation skills;
Must be organized, detail oriented and ability to multi-task in a fast paced environment;
Ability to work independently and as part of a virtual team where open, collaborative communication is expected;
Exhibits personal traits of curiosity, modesty, achievement orientation, and conscientiousness;
Team player that is creative, process oriented, and committed;
Excellent knowledge and use of Basic MS Office Suites (Excel, PowerPoint and Word);
Preferred Skills
Professionalism;
Leadership qualities;
Interpersonal communication abilities;
Compliance solving capabilities;
Problem solving & quick decision making ability;
Attention to detail and quality;
Good knowledge of Nigeria and International Regulatory laws;
Ability to keep confidentiality in respect of all matters handled.