Product and Process Management
Regulatory Affairs Manager Industry: Pharmaceutical Location: JHB Equity Requirement: EE Lead the Regulatory ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable) ensuring timeous processing of regulatory applications. Key Responsibilities: Manage work streams for- and report other MRA's and third-party stakeholders Review regulatory agency submission of materials to ensure timelines accuracy, comprehensiveness, or compliance with regulatory standards Co-ordination and submission of new
Senior Regulatory Pharmacist. Job Purpose: Support the Regulatory team to provide superior Regulatory services to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance with with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related ensuring timeous processing of regulatory applications. Key Responsibilities: Manage work streams for- and report stakeholders Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission
Senior Regulatory Affairs Pharmacist Industry: Pharmaceutical Location: Midrand Equity Requirement: EE EE Key Responsibilities: Manage work streams for- and report on the assigned portfolio of products Conduct with Regulatory Authorities, internal and external stakeholders Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced. Key Requirements: Pharmacy Council 3 to 5 years' experience in Regulatory Affairs, preferably in human medicines Demonstrable
Regulatory Affairs Scientist Industry: Pharmaceutical Location: JHB Equity Requirement: EE Large Pharmaceutical employ a Regulatory Affairs Scientist. The following applies: Key Responsibilities: Managing and coordinating applications. Managing and coordinating response to the regulatory authority. Maintain regulatory knowledge is required. Effectively managing, auditing and implementation of Regulatory systems Key Requirements: field Minimum 1-2 years' solid experience in Regulatory Affairs, preferably in orthodox, human medicines
looking for a Regulatory Affairs/Quality Assurance Pharmacist to join their team. Regulatory Affairs (RA): Assurance (QA): Assist QA Manager with artwork review and quality management system for Act 101 products release of Act 101 products in the absence of QA Manager and RP/Deputy RP. Review and update SOPs and Technical
A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge
ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable
relevant regulations in Africa.
Experience with regulatory authorities in sub-Saharan Africa and French
be advantageous
Significant experience of regulatory drug development, manufacture, commercialisation
commercialisation or equivalent.
Knowledge of regulatory procedures and legislation for drug development, product
submissions . Activities relating to product lifecycle management. Maintain and develop working relationships effectively effectively and provide required regulatory support. Reviewing artwork relating to products ensuring abreast of developments and changes in the local regulatory environment which directly impacts on the product Council (SAPC) is essential Minimum of 2 years Regulatory Affairs experience in pharmaceutical industry industry . Experience working with SAHPRA and other Regulatory Authorities in Africa. Excellent spoken and written
competent and experienced Regulatory Affairs Scientist for the Regulatory Affairs Department Key Job Compilation and update of documents to be submitted to regulatory authorities, this includes the compilation of to customer (both internal and external) and regulatory authority queries Ensuring that annual product according to internal procedures and in line with regulatory expectations Compilation of process qualification
Regulatory Affairs Manager Industry: Pharmaceutical Location: JHB Equity Requirement: EE Lead the Regulatory ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable) ensuring timeous processing of regulatory applications. Key Responsibilities: Manage work streams for- and report other MRA's and third-party stakeholders Review regulatory agency submission of materials to ensure timelines accuracy, comprehensiveness, or compliance with regulatory standards Co-ordination and submission of new