Regulatory Affairs Manager: GIB (Africa) (JHB/CPT) (Gauteng) at Pharma Dynamics (Pty) Ltd

Description

KEY RESPONSIBILITIES

• RA Management
• Manage the timeous compilation and submission of any due diligence report in line with allocated product priorities
• Compile and submit any TB and/or ARV dossiers within the agreed timelines to SAHPRA and other African countries as decided by Lupin GIB
• Provide technical assistance to Global Institutional business in line with Regulatory requirements and dossier format across Africa.
• Assist, in liaison for the Lupin GIB team with the regulatory Authorities across Africa the compilation and availability of all technical and/or pharmacovigilance agreements prior to the submission of new dossiers
• Manage the implementation of artwork and patient ready packs, in line with tender requirements and in liaison with the Responsible Pharmacist and Head of Institutional Business: South Africa and SADC Countries.
• Ensure any variations are logged on the CCP register and managed until completion
• Ensure all dossier related procedures, templates and quality standards are adhered to
• Maintain the product life cycle on an ongoing basis
• Manage and ensure implementation and availability of all pre- and post-registration commitments including, but not limited to validation reports, stability data, batch documentation, CEP updates
• Ensure all correspondence and or dossier information is filed appropriately
• Ensure all packaging material is current, in line with latest approvals across Africa and stored electronically wherever required in the Geography.
• Manage the compilation of all tender related SOP’s including new SOP’s, updates to existing SOP’s and reviews of outdated SOP’s in liaison with Regulatory Affairs, Quality Assurance and the Responsible Pharmacist
• Maintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate
• Quality Assurance
• Oversee QA operations for product realization, including Lot Release, stability programs, and technical transfers.
• Ensure an appropriate ongoing stability program is in place in liaison with the Associate Director: Quality Assurance
• Identify and manage the implementation of CAPAs in liaison with Quality Assurance and/or Regulatory
• Manage the GMP compliance of API’s and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist in the assigned geography.
• Manage the co-ordination and approval of Analytical Method Transfer, Stability studies, and risk assessments to meet timelines.
• Manage the compilation and updating of Technical Quality Agreements and conduct Product Quality Reviews.
• Maintain accurate electronic databases for dossiers and master data; ensure data integrity.
• Conduct supplier audits and manage Issue Logs to resolve quality concerns promptly.
• Ensure destruction processes, documentation practices, and QMS compliance are strictly followed.
• Manage the preparation and submit PIT exemption applications and manage correspondence with authorities effectively.
• External stake holders
• Liaise with the Regulatory Authorities in the assigned Geography with regards dossier recommendations, biostudies and/or clinical trials
• Assist in collaboration with Lupin RA to ensure dossiers comply to the relevant Regulatory Authority requirements in the assigned Geography
• Assist in collaboration with the Responsible Pharmacist and Head of Institutional Business: South Africa and SADC Countries with any technical matters relating to tender requirements involving the Department of Health

General

• Act as RP in the assigned Geography as and when
• Act as the deputy RP as and when needed in South Africa
• Perform any other duties as per changes in operational requirements of the
• Perform any other duties as
• Provide monthly and or weekly reports as and when
• Assist with collating and providing financial requirements for budget

Location

• This position is open to candidates being absed in Johannesburg or Cape Town.

Requirements

• Pre-requisites
• Experience in Regulatory Affairs and Quality Assurance
• BPharm degree