Regulatory affairs Officer in a reputable Pharmaceutical/FMCG

Adexen Recruitment Agency – Our client in the Pharmaceutical / FMCG industry is currently recruiting suitably qualified candidates to fill the position below:

 

 

Job Title: Regulatory Affairs Officer

Location: Lagos
Job Type: Full Time

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.
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Desired Skills and Experience

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

 

 

How to Apply
Interested and qualified candidates should:
Click here to apply

 

Note: We thank all applicants however only those selected will be contacted.

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