Job Purpose: The registration of new drug products and the maintenance of registration licences.
Major Accountabilities
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:
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
