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28/01/2015

AFRICSEARCH recruits REGULATORY AFFAIRS SPECIALIST-FWA

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AFRICSEARCH 
recruits 
REGULATORY AFFAIRS SPECIALIST-FWA

Référence : RAS-FWA

Position purpose

Coordination of the registration, re-registration, life cycle management, and Regulatory compliance of BHC products in French West Africa Countries

Local Quality Representative for French West Africa Countries

Major tasks and responsabilities of position

  • Monitors French West Africa Countries 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 regional office in Nairobi
  • Supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of Healthcare products;
  • Supports registration / re-registrations plan creation together with Head of Regulatory Affairs;
  • Supports registration / re-registration of BHC product portfolio, subsidiaries and if necessary companies-partners defined by Head of Regulatory Affairs in Middle Africa;
  • Ensures timely modification of NDA (when necessary) under laws and other acts as stipulated in the respective French West Africa countries;
  • Provides Representation offices and branches of countries depending on French West Africa Countries with approved country documents, registration certificates, NDA, leaflets, packaging, etc;
  • Provides regularly progress reports, puts regulatory dates together and supports entry into databases in liaison with the regional office in Nairobi;
  • Checks transfers of NDAs, quality certificate, packing materials marking, application instructions (structure, description, issue form, packing, storage terms and conditions). Supervises compliance of quality certificate to the standard documentation;
  • Participates in development of French West Africa Countries packing, labeling, 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;
  • Set up and support implementation and regular monitoring of the local Quality Management Systems for the local commercial operations;
  • 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 at Bayer;
  • Perform the role of responsible pharmacist for the Bayer West Africa Office in Abidjan; 

Value added

  • To ensure the registration and /or the re-registration of BHC products in French West Africa.
  • Helps to raise and maintain the profile of Regulatory Affairs and Global Quality Assurance functions within Bayer HealthCare, while balancing needs of external customers and stakeholders.
  • Contributor to decision making process involving business critical action regarding product quality and regulatory issues and crises.
  • Works with other business groups to ensure that Regulatory & Quality are represented and that knowledge of products in the French West Africa are brought into the RA & QA organization.
  • 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

Work relation

External Parties

  • Health Authorities ;
  • Other authorities and the organizations participating in registration, expertise and quality control of medicinal products
  • Industry and Professional Associations
  • Pharmaceutical Associations
  • Third party agencies and distributors

Internal Functions

  • Marketing and Sales
  • Global and Regional Regulatory Affairs functions
  • Medical Affairs
  • Product Supply
  • Quality Assurance
  • Pharmacovigilance
  • Legal
  • Contract management – e.g. regarding  local QA agreements 

Qualifications

  • 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), knowledge of French language is an added advantage;
  • Good Computer literacy;
  • Readiness to business travel;
  • Collaborative, team-oriented, flexible 

Informations supplémentaires :

Prière d'adresser votre candidature à recrutementci@africsearch.com en précisant en objet l'intitulé du poste .

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