Regulatory Affairs Specialist

2 weeks ago

Midrand, Gauteng, South Africa Hire Resolve Full time
Regulatory Affairs ManagerAbout the Role

Hire Resolve's client is actively seeking a highly skilled Regulatory Affairs Manager to join their team in a key role.

Key Responsibilities
  • Regulatory Strategy - Lead, manage, and execute strategic direction as the regulatory affairs manager.
  • Regulatory Documentation - Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
  • Regulatory Compliance - Provide input to the regulatory strategy in line with business objectives.
  • Safety Updates - Manage and implement safety updates where required.
  • Product Registration - Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
  • Licenses and Renewals - Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC).
  • SOP Development - Write and develop SOPs in line with Global SOPs.
  • Internal and External Audits - Manage internal and external audits (e.g., Global & SAHPRA).
  • Regulatory Document Management - Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
  • Product Complaints and Deviations - Manage product complaints and deviations.
  • Regulatory Filing System - Maintain regulatory documentation filing system.
  • Quality and Compliance - Ensure regulatory compliance and quality-related records are available and retained.
  • Product Recall - Coordinate product recall or market withdrawal when necessary.
  • Regulatory Updates - Obtain and distribute updated information on domestic and international laws.
  • Pharmacovigilance Reporting - Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
  • Pharmacovigilance Training - Conduct pharmacovigilance training for local staff.
  • Regulatory Authority Liaison - Answer requests from the Regulatory Authority in cooperation with Global Safety.
  • QMS Implementation and Maintenance - Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
  • Quality System Improvement - Identify areas for improvement within the quality system and implement corrective and preventive actions.
  • Quality Training - Provide training to staff on quality standards, regulatory requirements, and best practices.
  • Quality Documentation - Maintain and manage quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
  • Environmental Compliance - Ensure compliance with environmental regulations and standards at local, national, and international levels.
  • Product Releases and Customer Complaints - The manager will also manage releases of finished products, customer complaints etc.
Requirements
  • B. Pharm (Bachelor of Pharmacy).
  • Registration with the South African Pharmacy Council (SAPC).
  • 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.
  • Systems knowledge.
  • Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
  • Familiar with ZAZIBONA processes.
  • Competent and experienced in eCTD submissions.

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