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Regulatory Affairs Specialist

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

Job Title: Regulatory Affairs Manager

Company: The Globevest Group

Location: Midrand

Job Type: Permanent

Industry: Pharmaceutical

Job Reference: RDT.S.RAM

Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team in Midrand. The successful candidate will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.

Key Responsibilities
  • Lead and manage the regulatory affairs function to ensure compliance with relevant regulations and standards.
  • Develop and implement regulatory strategies to support business objectives.
  • Manage and maintain regulatory documentation, including product registrations and dossiers.
  • Provide input to the regulatory strategy and ensure compliance with current legislation.
  • Manage and implement safety updates, including product recalls and market withdrawals.
  • Handle license renewals and manage relationships with regulatory authorities.
  • Develop and maintain SOPs and quality records.
  • Manage internal and external audits and ensure compliance with industry standards.
  • Responsible for updates of dossiers and product information to ensure compliance with current legislation.
  • Manage product complaints and deviations.
  • 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 ADRs to Global Safety and SAHPRA and follow up on Adverse Drug Reactions.
  • 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.
  • The manager will also manage releases of finished products, customer complaints, etc.
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
POPIA

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We endeavour to reply to each and every application, however, should you not hear back from us within 14 days please consider your application unsuccessful.