Position: Regulatory Affairs Manager
Salary: Market related
Location: Midrand
Job type: Permanent
Industry: Pharmaceutical
Reference Number: RDT.S.RAM.16092024
COMPANY DESCRIPTION:
Our client is an international pharmaceutical company with offices in Midrand and they are looking for a Regulatory Affairs Manager to join their team as soon as possible.
JOB DESCRIPTION:
As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance in SEA Cluster. You will ensure that the company complies with all regulations and maintains Company’s pharmacovigilance requirements.
MAIN DUTIES & RESPONSIBILITIES:
- Lead, manage, and execute strategic direction as the regulatory affairs manager
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications
- Provide input to the regulatory strategy in line with business objectives
- Manage and implement safety updates where required
- Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations
- Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
- Write and develop SOPs in line with Global SOPs
- Manage internal and external audits (e.g., Global & SAHPRA)
- Responsible for updates of dossiers, PI/PIL 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 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
- 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.
EDUCATIONAL REQUIREMENTS:
- Grade 12
- B. Pharm
- Registration with the South African Pharmacy Council (SAPC)
EXPERIENCE AND SKILLS REQUIRED:
- 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
#J-18808-Ljbffr
