Drug Regulatory Affairs Manager East Africa Job Vacancy

Job Purpose: The registration of new drug products and the maintenance of registration licences.
Major Accountabilities
  • New Product Registrations – With minimum supervision, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome.
  • Maintenance of registered products – With minimum supervision, maintains registration of currently approved products; manage market authorization (MA) renewal process working closely with internal and external stakeholders.
  • Relationships within and outside the company - Develop and maintain good working relationships with company internal Global teams and provide valuable regulatory advice as necessary.
  • Review of Promotional Material – Review promotional material for assigned products against regulatory guidelines.
  • Company Licences and Pure Substance– Responsible for the maintenance and implementation of relevant importation and exportation licenses and the co-ordination of pure substance requests.
  • Timely and accurate Maintenance of Drug Regulatory Databases.
  • Ensure timely submissions of CTAs.
  • Other Drug Regulatory activities as may be defined from time to time.
Ideal Background
Education:
  • Tertiary qualified/University degree – Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
Experience and qualifications:
  • 5 years experience in regulatory affairs dealing with a wide variety of registration projects and issues.
  • Familiarity with Regulatory process and system in East & Central African region.
  • Proven track record of successful submissions of regulatory dossiers.
  • Expected to have achieved a high level of credibility with local regulatory authorities.
  • Strong team player with good interpersonal skills.
  • Ability to work independently with minimal supervision.
  • Willingness to travel and represent our company appropriately at Health Authorities.
Language (s)
  • English: Good written and oral communication skills required
  • Portuguese: Advantage
Applications & Detailed CV to be sent to this e-mail address, not later that 16 July 2010: drregulatory82@gmail.com