A global pharmaceutical company is seeking a Regulatory Pharmacist to ensure the Regulatory Department meets its statutory requirements in terms of the SA Pharmacy Act 53 of 1974, the Medicines and related Substances Act of 101 of 1965 and relevant Codes and Guidelines to ensure compliance and maintenance of the pharmaceutical manufacturing license.

• Compile new product submissions in line with current SAHPRA guidelines.
• Compile CTD conversions and post-registration amendment documentation in accordance with the applicable regulations which includes translating regulatory requirements into practical, workable submissions.
• Compile new product applications/variations/renewals in line with CEAM (Central East Africa and Mauritius) health authority requirements.
• To collect all the information/ specification required for amendment compilation.
• Review and approval of new and amended documentation, including printed packaging material and artwork.
• To provide thoughtful and accurate comments during document review, mindful of regulatory requirements.
• Access and approve of advertising and promotional material and ensure that the material complies with the registered information and relevant Regulations, Codes and SOP’s.
• To be certified with the Marketing Code Authority and advise relevant departments of the requirements, reviewing material.
• Update professional information and patent information leaflets, as per guidelines.
• Compile safety updates and responses to SAHPRA’s committee’s recommendations.
• Assist with translation of printed packaging material.
• Perform application of import permits and documentation of Narcotic substances and do follow up on this with the DOH.
• Compile Annual returns in respect of specifies S5 and S6 substances.
• Compile and submit to SAHPRA the annual forecast of specified Narcotic substances.
• Communicate with Principals to obtain information for submission to SAHPRA.
• Assist with the adverse drug reaction and pharmacovigilance process within the Regulatory Department.
• Assist with customer queries where required.
• To initiate change control requests.
• Without detracting from specific tasks and duties referred to in the job description, required to comply with any reasonable or instruction from the Head of Regulatory Affairs or RP, related to company functions from time to time.

Requirements:

• B. Pharm degree
• 24 months experience in pharmaceutical industry (Regulatory Affairs/ Quality)
• Registration with the South African Pharmacy Council
• Knowledge of SA Pharmacy Act, Medicine and related Substances Act, the SAPHRA guidelines and Marketing Code and good Manufacturing Practice Standards, good warehouse practice standards and good distribution practice standards
• Proficiency in English
• Computer literacy
• Accuracy, organised, decisive and goal oriented, quality and results oriented and pro-active.
• Attention to detail, a good listener, and a team player.
• Self-motivated, hands-on individual with a “can-do” attitude.
• Ability to work under pressure and adhere to strict deadlines.
• Ability to multi-task and prioritise and to accept responsibility and act on own initiative.