1. Regulatory Science Officer
Job Summary
The Regulatory Affairs Officer will support the Regulatory Affairs Manager in ensuring effective oversight of study protocols, procedures, and adherence to approved quality systems and practices. The incumbent will report to the Principal Investigator.
Key Responsibilities:
• Contribute to preparation and submission of project dossier applications, progress reports and correspondences and follow up through regular early regulatory inquiry and engagement with regulatory agencies.
• Represent project interests in domestic, regional and international regulatory, biosafety and environmental fora and events and provide relevant guidance on the correct interpretation of domestic and international policies, regulations including investigations in product complaints.
• Facilitate review of project SOPs and local working best practices to ensure their compliance with national, regional policies and regulations.
• Review project materials such as user manuals, SOPs and project progress reports to ensure that they are accurate and comply with established domestic and international regulatory standards and best practices.
• Participate in training, delivery and development of regulatory engagement messages at national, regional and international levels.
• Participate in internal project audits including laboratory and field trial inspections and communicate gaps to facilitate the implementation of relevant regulatory functions.
• Work closely with the stakeholder engagement teams to simplify current knowledge regarding product development information, train project staff on current and emerging regulatory policies and procedures.
• Organize engagement opportunities with regulators at national, regional and Pan African to learn from each other.
• The position holder would report directly to the PI and also be a liaison with the regulators.
Essential Requirements
o An Honors Bachelor’s Degree in any Science related field
o At least 2 years' relevant experience in the health research sector/regulatory science role.
o Knowledge of national and international research regulations/guidelines
o Knowledge of MS packages required.
o An individual with good communication and interpersonal skills, ability to pay attention to detail, multi –task and an excellent team player
o The incumbent should have good analytical skills and problem-solving ability
o S/he should be impartial and confidential
Further Information
All applications must be in English and include a Curriculum Vitae, a cover letter explaining why this position is attractive and why your profile fits, and three references.