Bayer Pharmaceuticals Regulatory Affairs Specialist Job in Kenya 2019
Job Employment Kenya: Bayer Pharmaceuticals Regulatory Affairs Specialist Job in Kenya 2019
Job Description: Today Work Kenya
Bayer Pharmaceuticals & Consumer Health a Division of Bayer East Africa Ltd, is one of the leading organizations worldwide with research and business activities focusing on; General Medicine, Specialty Medicine and Women’s Healthcare.
To maximise our commitment to sustainable medical health development, provide innovative products and medical solutions and stewardship, we seek to recruit a qualified and result oriented individual to fill the following position:
Regulatory Affairs Specialist
Ref No. 2019/HR/PH-006
Reporting to the Head, Regulatory Affairs & Quality Assurance, the Regulatory Affairs Specialist will be responsible for Registration, re-registration, life cycle management, and Regulatory compliance of Bayer Pharmaceuticals and Consumer Health products in Middle Africa and supporting maintenance of the local commercial operations Quality Management System.
Major Tasks and Responsibilities
- Supports planning and execution of Bayer Pharmaceuticals and Consumer Health products registration I re-registration as defined by Head of Regulatory Affairs in Middle Africa;
- Monitors Middle Africa countries requirements of registration and quality assurance of Bayer Pharmaceuticals and Consumer Health products. 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 assurance of Bayer Pharmaceuticals and Consumer Health products:
- Ensures timely fulfilment of modification / variations / lifecycle management of Bayer Pharmaceuticals and Consumer Health products (when necessary) under laws and other acts as stipulated in the respective Middle Africa countries:
- Participates in development of Middle Africa Countries packaging, labeling, application instructions and insert (checks conformity of NDA and, if necessary, puts relevant corrective amendments in place);
- Business support of the Representation Offices in Middle Africa and in country distributors I customers and partners as necessary by providing documents, registration certificates, NDA, leaflets, packaging material, tender business support.;
- Support implementation and regular monitoring of the local Quality Management Systems for the local commercial operations;
- Ensures and support 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 in Middle Africa.
Experience / Qualification
- University Degree in Pharmacy, and registered by the Pharmacy and Poisons Board
- Minimum 3 years of work experience in Regulatory Affairs, Quality Assurance, Product Development or Product Safety;
- Good knowledge of regulatory environment in the sphere of registration and certification of pharmaceutical products in Middle Africa:
- High self-motivation to complete processes even in challenging regulatory environment:
- Good command of English language (both oral and written), knowledge of French language is an added advantage
- Good Computer literacy
- Readiness to business travel
- Collaborative, team-oriented, flexible
Competencies: Manages Complexity, Customer focus, Drives results, Collaborates, Business insights.
How to Apply
If you meet the above requirements, please send your application letter, a detailed CV with three professional referees including daytime contact not later than 24th May 2019 to:
Applications received after the deadline will not be considered.
Only short-listed candidates will be contacted.