Regulatory Affairs Pharmacist / Specialist - Johannesburg
REPORTS TO: Head of Regulatory
DIRECT REPORT: 0
• Compile and 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, including artwork.
• 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 collect technical information relating to finished products during new product development (NPD) and to be part of the NPD process.
• To write clear, accessible product labels, patient information leaflets and package inserts.
• To ensure that Quality standards are maintained during dossier creation and propose improvements.
• To provide thoughtful and accurate comments during document review mindful of regulatory requirements.
• To finalise and present to the RP a completed dossier in the required format for final approval.
• To perform regulatory audits on product dossiers.
• To perform peer reviews on collegues’ dossiers.
• Migrate and maintain dossiers on the DocuBridge system.
• To develop and maintain current regulatory knowledge.
• To acquire published new or amended acts, regulations, bills and notices relevant to the pharmaceutical industry.
• To identify SOP’s and documentation that may be affected by new or amended legislation.
• To convey the implications of new legal requirements to the Head of Regulatory and Responsible Pharmacist.
• To supply technical information and registration support to the relevant departments and identify deviations from legislation and recommend corrective action.
• Reviewing all master documentation sent for approval by third party manufacturers.
• Approve artwork and marketing material according to the relevant SOP’s.
• Collect technical information relating to finished products during New product development and ensure departments are informed prior to product’s first market release
• Compile and amend all SOP’s to be in line with requirements and assist with implementation
• 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 initiation and monitoring of product stability testing and incorporating data in dossiers, when required.
• Assist with the advers drug reaction and pharmacovigilance process within the Regulatory Department
• Assist with customer enquiries where required.
• To supervise regulatory support staff when required.
• To be certified with the Marketing Code Authority, and advise relevant departments on the requirements.
• Without detracting from specific tasks and duties referred to in the job description, required to comply with any reasonable requests or instructions from the Head of Regulatory related to company functions from time to time.
QUALIFICATIONS / EXPERIENCE
• B.Pharm / Equivalent technical degree
• Experience in pharma/nutraceutical environment - advantageous
• 5-10 years' experience in the pharmaceutical industry (Production/Quality Assurance/Regulatory)
• Good knowledge of MS Office (Excel, Word, Adobe Pro, Power point, etc.) and Outlook.
• 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