Snr Regulatory Affairs Pharmacist

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

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

Requirements:

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