We at Pharma Dynamics seeks to employ an experienced Regulatory Pharmacist to manage the compilation, submission of ARV\/TB range of products in line with current legislation, operational requirements and business needs of Global Institutional Business.<\/p>\n
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Job Title: Regulatory Pharmacist<\/strong> Specification<\/strong> Dossier management<\/strong> External stake holders<\/strong><\/p>\n \u2022Liaise with the South African Regulatory Authority with regards dossier recommendations, biostudies and\/or clinical trials Technical queries and complaints<\/strong> Marketing support:<\/strong> General<\/strong> Requirements<\/strong> TECHNICAL COMPETENCIES REQUIRED<\/strong><\/p>\n \u2022Good knowledge of the Pharmaceutical industry and tender business BEHAVIOURAL COMPETENCIES REQUIRED<\/strong><\/p>\n \u2022Effective project management and process flow skills The company reserves the right to adjust or modify the scope and \/ or level of the job based on applicant supply, operational requirements and\/or prevailing market conditions.<\/p>\n
\nLocation:<\/strong> Tokai, Western Cape, South Africa
\nReference:<\/strong> # RAP 2020
\nContract Type:<\/strong> Contract 12 Months
\nSalary:<\/strong> Market Related<\/p>\n
\nUNDERTAKE THE RESPONSIBILITIES BELOW at a high level of functioning with minimal guidance:<\/p>\n
\n\u2022Manage the timeous compilation and submission of any due diligence report in line with allocated product priorities
\n\u2022Provide technical assistance to Global Institutional business in line with South African Regulatory requirements and dossier format
\n\u2022Assist, in liaison with the Responsible Pharmacist, Quality Assurance and Compliance, Cape Town, the compilation and availability of all technical and\/or pharmacovigilance agreements prior to the submission of new dossiers
\n\u2022Manage the GmP compliance of API\u2019s and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist
\n\u2022Manage the implementation of artwork and patient ready packs, in line with tender requirements and in liaison with the Responsible Pharmacist and State tender Manager
\n\u2022Compile and submit any TB and\/or ARV dossiers within the agreed timelines to SAHPRA and\/or neighboring countries
\n\u2022Ensure any variations are logged on the CCP register and managed until completion
\n\u2022Ensure an appropriate ongoing stability program is in place in liaison with the Technical Specialist and QA manager
\n\u2022Identify and manage the implementation of CAPAs in liaison with Quality Assurance and\/or Regulatory
\n\u2022Ensure all dossier related procedures, templates and quality standards are adhered to
\n\u2022Maintain the product life cycle on an ongoing basis
\n\u2022Manage and ensure implementation and availability of all pre- and post-registration SAHPRA commitments including, but not limited to validation reports, stability data and batch documentation
\n\u2022Ensure all correspondence and or dossier information are communicated to the administrative department thus ensuring electronic database updates
\n\u2022Ensure all packaging material is current, in line with latest SAHPRA approvals and stored electronically for South Africa and neighboring countries
\n\u2022Manage the compilation of all tender related SOP\u2019s including new SOP\u2019s, updates to existing SOP\u2019s and reviews of outdated SOP\u2019s in liaison with Regulatory Affairs, Quality Assurance and the Responsible Pharmacist
\n\u2022Maintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate<\/p>\n
\n\u2022Assist in collaboration with the Responsible Pharmacist and Tender Manager with any technical matters relating to tender requirements involving the Department of Health<\/p>\n
\n\u2022Manage, in liaison with PV Manager, and Responsible pharmacist all product related technical queries internally and from consumers or other healthcare professionals.<\/p>\n
\n\u2022Ensure factual and legislative compliance of all product related training material in liaison with the Compliance Department<\/p>\n
\n\u2022Perform any other duties as per changes in operational requirements of the department.
\n\u2022Perform any other duties as requested
\n\u2022Provide monthly and or weekly reports as and when required
\n\u2022Assist with collating and providing financial requirements for budget purposes<\/p>\n
\nPRE-REQUISITES
\n\u2022B. Pharm registered with the SA Pharmacy Council
\n\u2022Scientific degree with at least 2-3 years hands on experience within a Regulatory environment<\/p>\n
\n\u2022Ethical clinical trial experience
\n\u2022Good command of neighbouring country registration process
\n\u2022Computer literate and able to effectively use Excel, Word, Power point
\n\u2022Holds considerable technical expertise
\n\u2022Makes very few technical \/ functional errors
\n\u2022Produces a high volume of work at a consistent standard
\n\u2022Managerial or supervisory experience
\n\u2022Presentation skills<\/p>\n
\n\u2022Effective leadership and people management skills, including motivating staff and managing staff performance
\n\u2022Functions independently at a senior level
\n\u2022Displays appropriate judgment and expertise to problems at hand
\n\u2022Proactively anticipates problems and solves them constructively
\n\u2022Effectively balances technical and commercial requirements with minimal supervision
\n\u2022Professional and presentable
\n\u2022Effective written and verbal communication skills
\n\u2022Highly organized and good planning skills
\n\u2022Self-discipline and effective administration skills
\n\u2022Highly accurate and has good attention to detail
\n\u2022Positive attitude and self-motivated<\/p>\n