Regulatory Affairs Specialist at Workforce Group

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.
• 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.
• 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.
• 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;
• Good knowledge of regulatory environment in the sphere of registration and certification of pharmaceutical products;
• High self-motivation to complete processes even in challenging regulatory environment;
• Good command of English language (both oral and written)
• Good Computer literacy;
• 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