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Regulatory Affairs Pharmacist East Africa Job Vacancy

Job Title: Regulatory Affairs Pharmacist East Africa

Reporting To: Head of East Africa / Medical Affairs Manager SSA

Department: Medical Affairs

Application Closing Date: 15th June, 2011

Position Purpose

To effectively manage and control the registration process of all products in all East African markets including:

  • Obtaining essential marketing authorization for these products from the various Health Authorities.
  • Management and assurance of regulatory compliance of the registration function with respect to documentation.
  • Implement best practice in line with current legislation and standards of ethical and professional performance.
Key Performance Areas
  • Pro-actively Manage Regulatory Processes of Key Products (New Products, New Indications, Line Extensions and all other AstraZeneca products).
  • Effectively manage allocated projects.
  • Consolidate and strengthen Regulatory Leadership role and Market access priorities.
  • Drive development of Patient Risk Management Plans (PRMP) for new chemical entities and new indications.
  • Prepare, review and adhere to Standard Operating Procedures (SOP’s) and Local Guidelines.
  • Maintain administrative systems, e.g. reports, RAD priorities, policies and procedures.
  • Establish and maintain customer relationships and stakeholder partnerships.
  • Alignment of personal and company value
Minimum Requirements
  • Degree in Pharmacy
  • Registration with the Pharmacy and Poison Board of Kenya
Experience and Skills
  • Minimum 2-3 years experience in registration as well as Clinical aspects of pharmaceutical dossier preparation and submission in an ethical pharmaceutical environment, and preferably with some supervisory and/or management experience.
  • Computer literacy in MS Office Suite
  • Excellent written and verbal communication skills
  • Time management and planning skills
  • Strong interpersonal skills with a customer relationship focus
  • Strong negotiation and communication skills with key customers such as the PPBK and Global Regulatory Affairs.
  • Uncompromising attention to detail and accuracy
  • Drive towards delivery and results
  • Ability to work independently in a high pressurised environment
  • Co-ordinate and liaise with senior manager on resource and work plan allocations
  • Good knowledge of Medical Regulatory bodies in E. Africa
How to apply

Please apply to Lerato Moale (+27 11 797 – 6014)

or via e-mail to

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