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 Lerato.Moale@astrazeneca.com