Regulatory Affairs Specialist

3 weeks ago


Midrand, Gauteng, South Africa The Globevest Group Full time
Regulatory Affairs Manager Job Description

We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining our company's pharmacovigilance requirements.

Main Responsibilities:
  • Lead the development and implementation of regulatory strategies to ensure compliance with relevant regulations and industry standards.
  • Manage and maintain regulatory documentation, including product registrations, dossiers, and pharmacovigilance reports.
  • Provide input to the regulatory strategy in line with business objectives and ensure that all regulatory requirements are met.
  • Manage and implement safety updates, product recalls, and market withdrawals as necessary.
  • Develop and maintain SOPs in line with Global SOPs and ensure compliance with quality-related records.
  • Manage internal and external audits, including Global and SAHPRA audits.
  • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
  • Manage product complaints and deviations, and maintain regulatory documentation filing system.
  • Ensure regulatory compliance and quality-related records are available and retained.
  • 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 on Adverse Drug Reactions (ADRs).
  • Conduct pharmacovigilance training for local staff.
  • Answer requests from the Regulatory Authority in cooperation with Global Safety.
  • Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
  • Identify areas for improvement within the quality system and implement corrective and preventive actions.
  • Provide training to staff on quality standards, regulatory requirements, and best practices.
  • Identify areas for improvement within the quality system and implement corrective measures.
  • Maintain and manage quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
  • Ensure compliance with environmental regulations and standards at local, national, and international levels.
Requirements:
  • Grade 12
  • B. Pharm
  • Registration with the South African Pharmacy Council (SAPC)
Experience and Skills:
  • Minimum 10 years experience in Regulatory Affairs with human medicine and biologicals experience
  • Product registration and dossier maintenance
  • Pharmacovigilance experience and knowledge of SAHPRA submission portals
  • Launch procedures for new products
  • QA processes, APQRs, customer complaints
  • Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa
  • Microsoft Office Suite proficiency
  • Familiarity with ZAZIBONA processes and eCTD submissions


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