Snr Regulatory Affairs Pharmacist

Overview

Hire Resolve is seeking a Senior Regulatory Affairs Pharmacist to join our client’s team. As a Senior Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and managing the registration of pharmaceutical products.

Responsibilities

• Prepare and submit regulatory applications for the registration of pharmaceutical products
• Review and analyze regulatory documentation for accuracy and completeness
• Develop and maintain relationships with regulatory authorities
• Stay updated on changes in regulatory requirements and guidelines
• Provide regulatory guidance and support to cross-functional teams
• Ensure compliance with relevant regulations and standards
• Participate in regulatory audits and inspections
• Manage the maintenance and renewal of product registrations
• Provide training on regulatory compliance and best practices
• Conduct regulatory impact assessments for product changes and updates
• Collaborate with global regulatory teams on international registration projects

Requirements:

• B. Pharm (Bachelor of Pharmacy)
• Registration with the South African Pharmacy Council (SAPC)
• Minimum 5 years’ experience in Regulatory Affairs (must have experience with human medicine and biologicals)
• Experience in product registration (NCE)
• Maintenance of dossiers and updates
• Pharmacovigilance experience/knowledge of collecting and reporting
• Knowledge of SAHPRA submission portals
• Launch procedures for new products
• Knowledge and experience regarding QA processes, APQRs, customer complaints, etc.
• In-depth knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa related to dossier submissions and lifecycle management
• Knowledge of the Marketing Code
• Systems knowledge
• Competent and experienced in eCTD submissions
• Proficiency in Microsoft Office suite including Word, Excel, and PowerPoint at an Intermediate level
• Familiarity with ZAZIBONA processes

Contact Hire Resolve for your next career-changing move.

• Salary: negotiable.
• Our client is offering a highly competitive salary for this role based on experience.
• Alternatively, apply via our portal and email

Full Time

Company Social