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
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: firstname.lastname@example.org using ‘Regulatory Affairs Specialist’ as the subject title.
Application Deadline: 12th May, 2017.