Bayer HealthCare Regulatory Affairs Specialist Job in Kenya

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.
 

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 individual to fill the following position,
 

Regulatory Affairs Specialist

Ref No. 2014/HR/BHC-006)
 

Reporting to the Head of Regulatory Affairs Middle Africa region, the Regulatory Affairs Specialist’s primary role will be to ensure the registration and lifecycle management of BHC product portfolio.

Major tasks/ duties

• Create, maintain and supports contacts with Ministry of Health and other authorities and the organizations participating in registration, expertise and quality control of medicinal products in Middle Africa; while Monitoring requirements of registration, quality assurance and product maintenance of medicinal products and informing in a timely manner the Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales.
• Carry out all activities pertaining to registration and maintenance of product portfolio of the company, subsidiaries and if necessary companies-partners as defined by Head of Regulatory Affairs in Middle Africa.
• Business support of the Representation offices in Middle Africa as necessary by providing documents, registration certificates, NDA, leaflets, packaging material, tender business support.
• Ensures adherence to industry-specific codes of practice or conduct, advertising codes, regulatory directives and guidelines, as applicable to the role, and to the Program for Legal Compliance and Corporate Responsibility at Bayer Healthcare in Middle Africa.
• Participates in development and implementation of common Middle Africa packing, labeling, application instructions and insert (checks conformity of NDA and, if necessary, puts relevant corrective amendments in place), as well as providing the link between Product supply, Regulatory Affairs and Change Management functions
• Supports projects of business units through review and approval of promotional material; ensuring compliance of the company promotional material with the company and local country requirements
• Ensuring product supply chain compliance as well as the local quality representation (LQR); through active participation in Middle Africa Supply strategy projects and maintenance of the Quality System for the Commercial Operations in Middle Africa

Education /Experience /Skills/Abilities:

• University degree in Pharmacy
• 1 - 2 years of work experience in medical products registration
• Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products
• Analytical and conception thinking;
• Have demonstrated ability to produce timely results that are of high quality and accuracy
• Have strong communication skills and able to work closely with people in wide variety of disciplines at different levels within the organization
• Capable of representing the interests of the company effectively to a range of regulatory agencies and government officials
• A self-starter, systematic, hands-on and thorough with a goal oriented mindset
• Knowledge in developing protocols and analyzing data reports for registration requirements
• Have experience of compiling accurate and complete preparation of registration dossiers
• 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 the application letter) not later than 16th April 2014 to:

The Human Resources Manager,
E-mail: hr.ke@bayer.com

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