POSITION: Production Regulatory Affairs Pharmacist

JOB OBJECTIVE:
Assistance with dossier registrations in the African countries and collate all the data needed
Maintain registration documentation ensuring compliance with relevant legislation.
Provision of technical information and registration support to all relevant departments.
Review and approval of new and amended documentation.

RESPONSIBILITIES
• To create, update, submit and maintain product dossier registration documentation in accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submission plans and to develop and maintain timelines.
• To collect all the information/specifications required for dossier compilation.
• To provide thoughtful and accurate comments during document review mindful of regulatory requirements in each individual country.
• To develop and maintain current regulatory knowledge.
• To acquire published new or amended acts, regulations, bills and notices relevant to the pharmaceutical industry in African countries.
• Reviewing all master documentation sent for approval by third-party manufacturers.
• To initiate and facilitate change control requests and maintain the Change Control Register.
• To ensure that Quality standards are maintained and propose improvements.
• Assist with the adverse drug reaction and pharmacovigilance process for the African countries within the Regulatory Department
• To supervise regulatory support staff when required.
• To be able to apply for permits, CoPP’s and GMP certificates to be issued by SAHPRA, when needed for submission in the other African countries.
• To liaise with country agents and Regulatory Authorities
• Ensuring compliance with statutory regulations and quality requirements
• Monitor trend analysis on non-compliance and taking corrective and preventative actions
• To lead and control the quality assurance functional activities
• Preview and approve all contracts from suppliers and ensure compliance in their contracts
• To co-ordinate quality management systems in line with regulations and company goals
• To track, analyse and investigate customer complaints and ensure implementation of preventative measures

QUALIFICATIONS / EXPERIENCE B.Pharm / Equivalent technical degree
Experience in pharma environment – advantageous 5-10 years' experience in the pharmaceutical industry (Production/Quality Assurance/Regulatory)
Good knowledge of MS Office (Excel, Word, Adobe Pro, PowerPoint, Docubridge, etc.) and Outlook.

INHERENT REQUIREMENTS
Attention to detail
Self-motivated individual
Ability to work under pressure and complete tasks against deadlines
Excellent written and verbal communication skills
Excellent communication and interpersonal skills within a team context
Ability to multi-task and handle a few tasks simultaneously