Regulatory Affairs Manager 45 views

Purpose:

A pharmaceutical company is seeking a Regulatory Affairs Manager who will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance in SEA Cluster and ensure that the company complies with all regulations and maintains the company pharmacovigilance requirements

Key Job Outputs:

• 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 and 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 staff14
• 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
• Identify areas for improvement within the quality system and implement corrective measures
• 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.

Core Competencies:

• 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

Qualifications:

• Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC)

Experience:

• Minimum 10 years’ experience in Regulatory Affairs with human medicine and biologicals experience

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013