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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