Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

QUALIFICATIONS NEEDED:

• Bachelor's Degree in Pharmacy or Diploma in Pharmacy.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 3 to 5 years of related experience in the vaccine/biotech/pharmaceutical industry or equivalent.
• Thorough knowledge of the current Medicines and Related Substances Act, the current Pharmacy Act, and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration (eCTD) and legal compliance) and documentation management and product maintenance related to the product portfolio.
• Working knowledge of Pharmaceutical Manufacturing related legislation
• Knowledge of marketing code of practice.
• Experience in registering products in ZAZIBONA.
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation (Extedo.)

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by: -
• Receiving and submitting all applicable updates, post-registration amendments, resolutions, and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Compile and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21, and Clinical Trial Applications.
• Update and maintain dossiers to the latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross-functional synergies/ project work.
• Ensure product license and retention fees are paid on time.
• Provide regulatory advice and support when required to relevant stakeholders including but not limited to sales, marketing, supply chain, medical and commercial, S&I, and projects team with regards to the products.
• Assist RA Manager in follow-ups/responses on regulatory audits by third-party / NRA.
• Regulatory Intelligence: Assist RA Manager to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, and trends) and changes in the local regulatory and international environment which directly impact Company's products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits.
• Writing / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per the QA calendar.)
• Provide guidance in opening and closing out of Change Controls/ NCRs / CAPAs to support QAs processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the company's applications when required.
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, coordination, and accuracy of all dossiers and correspondence.
• Approve promotional material (advertising) when required.
• Assist in establishing the annual regulatory budget.
• On request from the Responsible Pharmacist, (in the absence of the Regulatory Affairs Manager), Deputise as the Responsible Pharmacist in the absence of the Responsible Pharmacist