| Date | 2024-06-08 |
|---|---|
| Job Title | Snr Regulatory Affairs Pharmacist |
| Employer | Hire Resolve More Information |
| Salary | 0 |
| Category | Logistics |
| Location |
Gauteng / Johannesburg |
Job Summary
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.