Regulatory Compliance Manager

Job Summary

• 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 a Bachelor’s degree in sciences preferred;
• 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;

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.

Application Closing Date
Not Specified.

How to Apply
Interested and qualified candidates should:

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