Regulatory Affairs Manager

Details of the offer

Hiring: Regulatory Affairs Manager Location: Midrand, South Africa As a Regulatory Affairs Manager, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.
Key Responsibilities Regulatory Strategy: Lead and manage regulatory strategies and documentation.
Documentation: Ensure compliance with regulatory requirements, update dossiers, and develop SOPs.
Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.
Audits: Manage internal and external audits.
Pharmacovigilance: Report and follow up on ADRs; provide local staff training.
QMS: Implement and maintain the Quality Management System, identify improvements, and provide training.
Environmental Compliance: Ensure adherence to environmental regulations.
Additional Duties: Handle product recalls, manage complaints, and stay updated on laws and regulations.
Requirements Education: Bachelor of Pharmacy (B. Pharm) and SAPC registration.
Experience: At least 10 years in Regulatory Affairs with human medicine and biologicals.
Skills: Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite.
Knowledge of ZAZIBONA and eCTD submissions is essential.
Personal Qualities: Detail-oriented, adaptable, organized, and a strong communicator


Nominal Salary: To be agreed

Job Function:

Requirements

Senior Global Regulatory Affairs Specialist

Senior Global Regulatory Affairs Specialist - Warsaw, Poland - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organizati...


Icon - Gauteng

Published a month ago

Senior Legal Counsel

Empowering Africa's tomorrow, together…one story at a time.With over 100 years of rich history and strongly positioned as a local bank with regional and inte...


Absa Group - Gauteng

Published 12 days ago

Satic - Junior Commercial Lawyers

Management LevelSenior AssociateJob Description & SummaryA career in our Corporate Law practice, within Legal Services, will provide you with the opportunity...


Pwc - Global - Gauteng

Published 12 days ago

Legal Support Administrator

DutiesAdhere to procedures and policies in place and aid in improving procedures regularly.Ensure that monthly tasks and reporting outputs are delivered on t...


Bidvestfacilitiesmanagement - Gauteng

Published 12 days ago

Built at: 2024-12-24T03:11:56.847Z