Regulatory affairs Manager
Curiska Johannesburg
Hiring: Regulatory Affairs Manager
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.
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
Jordan HRMidrand, 25 km from Johannesburg
Qualifications
Bachelors Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Experience
• 5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines...
Jordan HRMidrand, 25 km from Johannesburg
Qualifications
• Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Relevant experience
• Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines
• Demonstrable...
Johannesburg
Overview
The Regulatory Affairs Manager for Human Medicine and Biologicals will be responsible for ensuring compliance with all regulatory requirements for the development, registration, and marketing of pharmaceutical products and biologicals...