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 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.

Requirements

• B. Pharm (Bachelor of Pharmacy).
• Registration with the South African Pharmacy Council (SAPC).
• 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
• Systems knowledge.
• Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
• Familiar with ZAZIBONA processes.
• Competent and experienced in eCTD submissions.

Benefits

Contact Hire Resolve for your next career-changing move.

• Salary: negotiable.

Apply for this role today contact Rebecca Grylls, Ashley Feldtmann, Thomas Stacey, Miné Roux at Hire Resolve or on LinkedIn

You can also visit the Hire Resolve website: hireresolve.us or email us your CV:  manufacturing@hireresolve.za.com

We will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.