Regulatory Affairs Specialist

By Live Lover -

Bayer HealthCare (BHC), a division of Bayer East Africa Ltd, combines the global activities of the divisions Animal Health, Pharmaceuticals, Consumer Care and Medical Care. Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

In Middle Africa, BHC is present in 41 countries, with its head office in Nairobi, Kenya.
To maximise our commitment to sustainable medical health development, provide innovative products, medical solutions and stewardship through product life-cycle management, we seek to recruit qualified and result oriented individuals to fill the following position;

Regulatory Affairs Specialist: (Ref No. 2013/HR/BHC-001)
Reporting to the Head of Regulatory Affairs Middle Africa region, the Regulatory Affairs Specialist’s position purpose will be the registration / re-registration of company Healthcare products.

 Major Tasks of the Position
• Monitors the country’s requirements of registration and quality control of medicinal products and timely informs Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales;
• Supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of medicinal products;
• Works out registration / re-registrations plan together with Head of Regulatory Affairs and Regulatory Affairs Manager;
• Supports duly registration / re-registration of product portfolio of the company, subsidiaries and if necessary companies-partners defined by Head of Regulatory Affairs in Kenya coordinating actions with Regulatory Affairs Manager
• Ensures timely modification of NDA (when necessary) under laws and other acts as stipulated in the respective country
• Provides Representation offices and branches of countries depending on the country with approved documents, registration certificates, NDA, leaflets, packaging, etc;

Education/Skills
• University degree in natural science (pharmacy is preferable);
• Minimum 3 years of work experience in medical products registration;
• High level of knowledge of the Company and competitors product portfolio;
• Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products;
• Analytical and conception thinking;
• Punctuality and duty performance;
• Ability to work under stress;
• Good command of English (both oral and written);
• Advanced user of PC: MS Windows, Internet;
• Readiness to business travel.

How to apply:
If you meet the above requirements, please send your application letter, a detailed CV with three professional referees including daytime contact, copies of certificates and testimonials (quoting the reference number on both application letter and envelop) not later than 3rd April 2013 to:

The Human Resources Manager, Bayer East Africa Ltd, PO Box 30321 – 00100 GPO, Nairobi. E-mail: hr.ke@bayer.com

(Applications received after the deadline will not be considered. Only short-listed candidates will be contacted)

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