Pharmaceutical Regulatory Affairs Specialist at Bloom Public Health

Job Description

• The RA Specialist will report to the Technical Director.Principal AccountabilityRepresent the team in the effective provision of regulatory support to clients and project teams.
• Coordinate the preparation and/or review of eCTD submission documents and other assigned tasks within established timelines and with high quality in terms of content, organization, accuracy, format, consistency, and adherence to regulatory requirements, guidelines, styles, and processes.
• Support the submission of regulatory dossiers and addressing responses, including WHO Prequalification, New Drug Applications (NDA), Marketing Authorisation Applications (MAA) and other international submissions.
• Support clients in developing and executing key regulatory initiatives and ensure routine regulatory submissions and processes are compliant with current regulations and guidance.
• Communicate effectively with clients and internal teams to ensure continuous operational compliance.
• Management of all controlled documents and records, applying the principles of Good Document Management Practice and data integrity.
• Provide training activities and maintain records for training within the business, project and team members.

Requirements

• The ideal candidate should have:Minimum 5 years’ experience in pharmaceutical regulatory affairs.
• Adept in the development of regulatory dossiers in the CTD format.
• Experienced regulatory professional having managed major submissions and approvals with some knowledge of international regulatory pathways, including WHO.
• Minimum bachelor’s degree in a science discipline.
• Ability to plan and organise work processes
• Excellent leadership and communication skills
• Proficiency in use of the computer and Microsoft office programs
• Relate well with others and be able to influence them positively
• Ability to analyse situations and make informed decisions
• Understanding and right application of the company’s values