Job Description

A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist.
Job Purpose:

• 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.
• The job incumbent is responsible for the co-ordination, project control and regulatory support for South Africa and Africa.

Main Duties and Responsibilities are:

• Keeping abreast of regulatory requirements in South Africa and Africa.
• Ensure compliance in line with the Medicines Act-SA and Pharmacy Act.
• Conduct due diligence on dossiers sourced from third parties and global offices.
• Maintain dossiers as variations are received from HQ or product principals or local manufacturers and ensure relevant submissions and approvals to Regulatory Authorities are being made.
• Download information from external portal i.e., Docubridge, sharepoint, Wetransfer and company drives.
• Compile new product dossiers and variations for submission to SAHPRA and African Health Authorities for approval.
• Compile eCTD and CTD new product submissions, conversions and post-registration amendments in accordance with the applicable regulations.
• Liaise and communicate with QA, Supply Chain, Commercial and PV departments to ensure compliance and alignment with the various function
• Assist with follow up strategies to obtain product registrations and variation approvals.
• Review and approval of new and amended documentation, including printed packaging material artwork.
• Respond to product-specific queries from principals/countries.
• Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
• Access and approval 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 unit's recommendations.
• Assist with translation of printed packaging material.
• Communicate with Principals to obtain information for submission to SAHPRA.
• Assist with customer queries where required.
• Finalise and present to the RP completed material in the required format for final approval.
• Initiate change control requests.
• Schedule Microsoft team meetings or teleconferences as needed.
• Ensure prior approval is obtained for local country expenses.
• Standardize folder structures and save information on NRD.
• Peer review of documentation prepared by registration assistants.
• Compile and maintain spreadsheets and status reports as needed and upon request.
• Compilation of work map trackers to ensure visibility of tasks.
• Ensure registrations are obtained in a timeous manner.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Comply with any reasonable instruction from the Head of Regulatory Affairs or RP, related to company functions from time to time.
• Completion of all assigned training within the specified timelines.
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
• Support business objectives and requirements

Qualifying Requirements are:

• Related Degree
• Driver's license
• Minimum of 3-5 years Regulatory Affairs experience in the Pharmaceutical industry
• Registration with the South African Pharmacy Council
• Knowledge of SA Pharmacy Act and Regulations, Medicine and related Substances Act and Regulations, the SAPHRA guidelines and Marketing Code and good Manufacturing Practice Standards, Good warehouse practice standards, good distribution practice standards and African Guidelines.
• Excellent Verbal and Written Communication
• Ability to manage time effectively
• Advanced Interpersonal Skills
• Knowledge of electronic document management systems/Docubridge; DrugTrack; TrackWise
• Proficiency in English
• Computer Literacy - MS Office Suite (Word, Excel, PowerPoint, Outlook)
• Embodies Values & Behaviours in all internal and external interactions.

Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com
Should you not receive feedback within 7 days, please accept your application as unsuccessful

Skills Required