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:
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
Please apply to Lerato Moale (+27 11 797 – 6014)
or via e-mail to Lerato.Moale@astrazeneca.com
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