AstraZeneca Regulatory Affairs Pharmacist Job in East Africa

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 Lerato.Moale@astrazeneca.com

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