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Regulatory Affairs Pharmacist

2 months ago

Johannesburg, Gauteng, South Africa Curiska Full time

Job Overview:

As a key member of the Curiska team, the Regulatory Affairs Pharmacist will play a crucial role in ensuring the seamless product registration process and dossier maintenance. This position requires a deep understanding of regulatory guidelines and technical requirements, as well as excellent leadership and management skills.

Key Responsibilities:

  • Provide strategic direction and lead the regulatory affairs team to ensure compliance with all regulations and maintain company pharmacovigilance requirements.
  • Ensure that regulatory documentation meets relevant regulatory requirements and specifications, and provide input to the regulatory strategy in-line with business objectives.
  • Manage and implement safety updates, Chemistry Manufacturing and Controls (CMC / P&A) updates and variations, and ensure approval and compliance of printed packaging material and promotional marketing material.
  • License renewals with service providers, writing and developing of SOPs, and managing internal and external audits.
  • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation, and managing and maintaining regulatory documentation filing system.
  • Ensure regulatory compliance and quality related records are available and retained, and coordinate product recall or market withdrawal when necessary.
  • Obtain and distribute updated information on domestic and international laws, report ADR to Global Safety and SAHPRA, and follow-up of Adverse Drug Reactions (ADRs).
  • Pharmacovigilance training of local staff, answering of requests from the Regulatory Authority with co-operation with Global Safety.

Minimum Requirements:

  • Education: B. Pharm (Bachelor of pharmacy) and registration with the South African Pharmacy Council (SAPC).
  • Job Training and Experience: Minimum 5 years' experience in Regulatory Affairs, with human medicine experience and biologicals, and experience in Product registration (NCE), maintenance of dossiers and updating thereof, pharmacovigilance experience/knowledge of collecting and reporting, knowledge of SAHPRA submission portals, launch procedures for new products, and knowledge of QA processes, APQRs, customer complaints, etc.
  • Systems knowledge: Microsoft office suite including Word, Excel, Power Point at an Intermediate level, familiar with ZAZIBONA processes, and competent and experienced in eCTD submissions.