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
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