Regulatory Affairs Officer at Adexen

Responsibilities

• To ensure that the company is in full compliance with regulatory requirements and to support in Planning and coordination of regulatory activities.
• Assembling of information and documents for new products registration, as well as formula changes and variations in existing products, and submission to NAFDAC and other relevant authorities for approval.
• Tracking of product Registration and ensure timeliness of renewal of existing Products.
• Compilation of product Dossiers received from Manufacturers in formats acceptable by the regulatory agency.
• Preparation and submission of regulatory agency applications, reports, or correspondence.
• Assist in developing regulatory strategies and implementation plans for the preparation and submission of new products.
• Online Application for API permits, Excipient permits, Narcotic permits, and other relevant permits in the single trade portal.
• Timely enrolment of all product certificates in the single trade portal.
• Assist in the coordination and monitoring of Clinical Studies of the Company’s products.
• To keep other departments in the company updated on regulatory requirements.
• Ensure timely submissions and approvals of applications according to regulatory plan and strategy, ensuring continuity of supply and regulatory compliance.
• Review materials such as detailing materials, information leaflets and packaging artworks to ensure that regulatory agency requirements are met.
• Ensuring regulatory compliance in adverts and getting approval on planned promotional materials.
• Communicating regulatory issues with the Regulatory Affairs Manager and other related departments and formulating appropriate responses.
• Assist in activities such as audits, regulatory agency inspections, or product recalls.
• Assist in Coordination of destruction of expired and rejected products and materials.
• Documentation of reported Adverse Drug Reaction and Enforcement / Pharmacovigilance as regards faking or any other issues relating to assigned products.
• Assist in documentation efforts to ensure compliance with domestic and international regulations and standards.
• Registration of company premises, Supt. Pharmacist and key Managers with the Pharmacists Council of Nigeria, PCN. OTHER DUTIES QMS & cGMP RESPONSIBILITIES (ISO 9001, NAFDAC, WHO & OTHERS).
• Represent the department on QMS and cGMP activities.
• Coordinate QMS and cGMP documentation, implementation & audit-related activities in the department.
• Disseminate information on QMS and cGMP implementation to other staff in the department.
• Identify QMS and cGMP improvement issues in the department and bring such up for the management representative’s consideration.
• Complete Corrective Action and Preventive Action Plan for gaps (non-conformances) picked in the department during any inspection and ensure closeout of such.
• Provide adequate assistance to external auditors in compliance reviews.
• Participate in all internal audits, report writing, and presentations at the monthly meetings as the need arises.
• Any other assignment as delegated by the Regulatory Affairs Manager.

Desired Skills and Experience

• Bachelor's Degree in Pharmacy
• Minimum of 3 years of Regulatory Experience in the industry.
• Good working knowledge of Regulations and current industry practices.
• Management skills: team building, decision-maker, leadership and communication.
• Experience in production, quality and safety processes
• Good knowledge GMP rules, QMSs and Regulatory guidelines.