Regulatory Affairs Pharmacist

7 months ago

Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 71064

**Job Type**
- Permanent

**Job Title**
- Regulatory Affairs Pharmacist

**Computer Skills**
- Adobe Acrobat,MS Excel

**Industry**
- Manufacture

**City**
- Johannesburg

**Province**
- Gauteng
- Reporting to RA Systems Manager**Job purpose**
- Maintain applicable regulatory affairs information management electronic systems, ensuring accurate system usage and data integrity by all stakeholders.
- Ensure accurate and timeous system administration.

**Key Job Outputs**
- Create, review and maintain accurate data in company electronic regulatory affairs information management system(s)
- Interpret, record and action Regulatory Authority correspondence accordingly in applicable electronic regulatory affairs system(s)
- Development, implementation, training and maintenance of the procedures and processes
- Data analysis and report generation for the company Business
- Provide support to cross-functional departments
- Establishes and maintains relationships with stakeholders and vendors
- Manage the Regulatory Helpdesk by resolving queries within agreed timelines
- Work in close collaboration with the IT department on upgrades, back ups and support of the RA electronic operating systems and ensure relevant actions are timeously updated
- Ensure good document practice is maintained in the department.
- Partake in internal and external audits, as required
- Provide applicant admin support**Inherent Requirements**

**Required Learning**
- B.Sc degree
- Intermediate skills in Excel and Adobe Acrobat
- A minimum of 1-2 years’ experience in Regulatory Affairs
- Experience in eCTD compilation/ administration and electronic processing would be an advantage.
- Experience in regulatory information data management would be an advantage

**What Qualification**
- B.Sc Degree

**Minimum Qualification**
- Bachelors

**Status**
- Available

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