Jobs 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

go to method of application »

Job Description

• To support our growing list of pharmaceutical projects across Africa, Bloom Public Health is currently seeking for a high calibre professional with expertise in Good Manufacturing and Distribution Practice (GMDP) to function in the capacity of Pharmaceutical GMDP Specialist.

Responsibility:

• The GMDP Specialist will ensure that all assigned pharmaceutical projects are delivered in compliance with current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), as well as regulatory and statutory requirements as applicable. The GMDP Specialist will report to the Technical Director.

Principal Accountability

• Represent the team in the provision of technical and quality assurance oversight activities, including projects relating to Good Manufacturing Practice (GMP), Quality Control (QC), Good Distribution Practice (GDP), Pharmaceutical Quality System (PQS), Technology Transfer and Quality Risk Management (QRM).
• Communicate effectively with clients and internal teams to ensure continuous operational compliance.
• Participate in investigations and provide expert advice, including root cause analysis and CAPAs.
• Technical review of GMDP documents, including SOPs, change controls, deviations, product incidents, risk assessments, CAPAs, protocols, and reports
• Management of all controlled documents and records, applying the principles of Good Document Management Practice and data integrity.
• Participate and provide support for third party audits
• Assist with continuous improvement and development/improvement of PQS.
• Provide training activities and maintain records for quality training within the business, personal, project and team members.

The ideal candidate should have:

• Minimum 5 years’ experience in a pharmaceutical manufacturing environment (preferably in Quality Assurance and Production)
• Minimum bachelor’s degree in a science discipline (preferably life science, pharmacy or engineering)
• Adept in the application of WHO GMP, GDP and other international standards
• Experience in the conduct of GMDP audits
• 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