- Job Title Regulatory Affairs Pharmacist - Half Day
Based in Midrand
Part-Time Regulatory Affairs Pharmacist who will support the RA Head in Johannesburg . It is a half day – part time position.
• Responsible for allocated product portfolio.
• Compilation and submission of new product applications, line extensions and/or new indications in line with the business plans/projects and as per the regulatory timetable in order to ensure Timeous registration and launch of new products in the respective countries.
• Submission of Package Insert/Patient Information Leaflet updates for registered products within the required time lines in order to ensure that the product package insert contains the most recent Safety data and other relevant information.
• Life-cycle management: submission of post-registration variations and/or dossier renewals for registered products within the required time lines in order to ensure regulatory compliance in line with local Health Authority regulations.
• Ensure rapid communication to relevant colleagues in the case of a change in regulatory
submission or approval time lines and/or potential regulatory related risk to the overall business.
• Review of regulatory documents/dossiers received from Global RA or third party companies and communication of additional data requirements for South Africa, Namibia and Botswana.
• Submission of PSUR’s & DSUR’s in line with the respective Corporate and Health Authority
Requirements and within the prescribed time lines.
• Maintenance of the product master files.
• Proof-reading of artwork (via the AMT system) in line with corporate time lines; proof-reading of MIMS and MDR as required.
• Ensure cross-functional teamwork and collaboration (e.g. support of launch meetings and plans, tender applications where relevant, regular communication/updates, participation in brand plan meetings, business meetings, etc.) with all stakeholders involved in the business, e.g. management, marketing, medical, quality, supply chain, etc.
• Remains constantly involved with the dynamics of the regulatory affairs environment via active participation and involvement in local professional associations e.g. SAPRAA, SAAPI, etc.
• Constantly monitors the regulatory environment in the respective countries by studying and/or commenting on draft or new regulations, guidelines, documents etc. issued by the relevant Health Authorities.
• Ensure that the relevant Corporate Databases (e.g. RequireBase, GVD, etc.) for the countries/products are updated and maintained within the stipulated time lines.
• Ensure compliance with all corporate, regional and local SOPs, Procedures, KMeds, etc.
• Ensure R&U of all required SOPs, Policies, etc. in LOS within the prescribed time lines.
• Ensure compliance with CAPA requirements and time lines.
• Develop a Quality excellence culture within the SA Regulatory operation.
• Maintain data integrity of corporate systems and databases such as CPD3, SLCI, AMT, etc.
Minimum Education/Degree Requirements
• Pharmaceutical degree
Required Capabilities (Skills, Experience, Competencies)
• Minimum 4 years of experience in regulatory affairs in the pharmaceutical industry
• Customer approach with high business understanding
• Result orientation and managing ambiguity in difficult situation
• Creativity on finding solutions with ‘can do’ approach
• Setting direction and leading change
• Managing people; attracting and developing talents
• Time management
Please send you CV to Vicki at firstname.lastname@example.org