Workforce Group – Our client a multinational chemical, Pharmaceutical and life sciences Company, founded over a century ago is recruiting suitably qualified candidates for the position below:

Job Title:
Regulatory Affairs Specialist
Location: Lagos
Tasks and Responsibilities

  • Monitors country requirements of registration and quality control of Healthcare products. Timely informs Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales;
  • Coordinate the activities of the regulatory affairs third party service provider in liaison with the other regulatory affairs functions
  • Supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of products;
  • Supports registration / re-registration of the client’s product portfolio, subsidiaries
  • If necessary companies-partners defined by Head of Regulatory Affairs in Middle Africa;
  • Provides regularly progress reports, puts regulatory dates together and supports entry into databases in liaison with the regional office in Nairobi;
  • Participates in development of country packing, labelling, application instructions and insert (checks conformity of NDA and, if necessary, puts relevant corrective amendments in place);
  • Timely provides other departments with copies of registration certificate, approved specification, description of packaging, marking and maintenance aspects of the products;
  • Ensures adherence to industry-specific codes of practice or conduct, advertising codes, regulatory directives and guidelines, as applicable to the role, and to the Program for Legal Compliance and Corporate Responsibility.
  • Perform the role of responsible pharmacist for the client’s Office in Lagos;
  • Responsible for the oversight of quality processes (e.g. GMP/GDP) and their implementation within the country platform.
  • Provides Regulatory and Quality Assurance expertise to cross functional groups including legal counsel.
  • Enhances good communications and collaboration between all internal and external customers, while at the same time ensuring that the highest Regulatory and Quality standards are maintained.
  • Remains current with changing regulatory requirements, ensuring company compliance with current legislation and regulatory demands.
  • Influential in withdrawal of products from the market; contributes to control the impact such issues can have on the company.
  • Exercises excellent judgement on critical drug quality and regulatory issues and optimal product quality and safety action based on pharmaceutical knowledge.
  • Ensure inspection preparedness, review departmental performance following defined targets and KPIs and take corrective actions as necessary.
  • Ensures Quality compliance within country organization.
  • Maintains local Quality Management System (in line with local regulations and global QMS)
  • Represents Quality in Senior Management of the country (e.g. QMR)
  • Leads the Quality country organization and has interlinkage to local functions performing quality (e.g. GDP/GMP) relevant processes (e.g. SCM)
  • Acts as interface to Managing Director and Cluster Quality Head on country-related Quality topics for marketed products
  • Ensures quality training (e.g. GMP /GDP) for the local organization
  • To ensure the registration and /or the re-registration of the client’s products in Nigeria.
  • Assures license to operate in the countries
  • Contributor to decision making process involving business critical action regarding product quality and regulatory issues and crises.
  • Acts as decision-maker for all operational Quality matters in respective Quality country organization
  • Ensures independent decision-making of Quality from business to avoid conflict of interest
  • The position holder has direct influence on the country’s EBIT by preventing major authority enforcements due to non-GMP/GDP compliance. Such enforcements can easily result in financial damage and severe loss of reputation at authorities, patients and customers.

Who you are

  • University Degree in Pharmacy
  • Minimum 3 years of work experience in Quality Control, Product Development or Regulatory Affairs;
  • High self-motivation to complete processes even in challenging regulatory environment;
  • Good command of English language (both oral and written)
  • Good Computer literacy;
  • Good knowledge of regulatory environment in the sphere of registration and certification of pharmaceutical products;
  • Readiness to business travel;
  • Collaborative, team-oriented, flexible

Purpose of your Application

  • Coordination of the registration, re-registration, life cycle management, and Regulatory compliance of the client’s Products in Anglo West Africa Countries (Nigeria, Ghana, Liberia, Sierra Leone and Gambia)
  • Act as responsible Pharmacist for the client’s Office in Nigeria
  • Responsible for an efficient local Quality Management System and compliant Quality process execution within Quality Country platform organization
  • Accountable for end-to-end Quality oversight for all products marketed in the respective countries
  • Accountable for Quality oversight for Good Distribution Practice (GDP) processes and their implementation within the countries

How to Apply
Interested and qualified candidates should forward their CV’s to: using ‘Regulatory Affairs Specialist’ as the subject title.

Application Deadline: 12th May, 2017.


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