Regulatory Affairs Specialist at Bayer East Africa

Ref No. 2020/HR/PH-010

Reporting to the Head, Regulatory Affais & 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, deputizing the Country Quality Head.

Major Tasks and responsibilities

• Planning and execution of assigned Bayer Pharmaceutical and Consumer Health products, registration / re-registration and lifecycle management
• Monitors Middle Africa countries requirements of registration and quality assurance of Bayer Pharmaceuticals and Consumer Health products;
• Supports contacts with Ministry of Health and other authorities and the organisations participating in registration, expertise and quality assurance of Bayer Pharmaceutical and Consumer Health products
• Business support of the Representation offices in Middle Africa ad in-Country distributors / customer and partners
• Support implementation and regular monitoring of the local Quality Management Systems for local commercial operations;
• Ensure 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 / Qualifications

• University Degree in Pharmacy, and registered by the Pharmacy and Poisons Board
• 1-4 years of work experience in Regulatory Affairs, Quality Assurance, Product Development or Product Safety
• Knowledge of medicines regulatory environment in Middle Africa
• High self-motivated 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

Competencies: Manages Complexity, Customer Focus, Drives Results, Collaborates, Business Insights