Regulatory Affairs Pharmacist

3 weeks ago

Johannesburg, South Africa Unique Personnel Full time

**Job Number**
- 72989

**Job Type**
- Permanent

**Job Title**
- Regulatory Affairs Pharmacist

**Computer Skills**
- Ms Office

**Industry**
- Manufacture

**City**
- Johannesburg (Incl. Northern Suburbs)

**Province**
- Gauteng
- Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose**
- To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers and tracking Regulatory Activity.
- Ensure compliant and timeous processing of regulatory submissions and commitments as assigned.
- To ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable), including the South African Health Products Regulatory Authority (SAHPRA) and South African Pharmacy Council (SAPC)

**Key Job Outputs**
- Entry Level position to Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of dossiers
- Tracking Regulatory Activity
- Internal training
- Assisting with internal product queries from relevant departments
- Effectively managing activity within Regulatory, QA and administrative systems
- Preparing, reviewing and adhering to Standard Operating Procedures and Regulatory Guidelines.**Inherent Requirements**

**Required Learning**
- Bachelor of Pharmacy
- Minimum 1 year Regulatory Affairs experience but significant QA experience in pharma environment
- Computer literate with prior experience with MS Office, Document Management System and / or Quality Management Systems

**Core Competencies**
- Attention to detail
- IT skills, document management skills
- Project management skills
- Good language skills
- Ability to prioritize and work to tight deadlines
- Systems approach
- Cross Functional skills: Ability to network, liaise and negotiate with others
- Ability to set standard and objectives and monitor progress
- Problem solving and decision-making skills

**What Qualification**
- Bachelor of Pharmacy

**Minimum Qualification**
- Bachelors

**Status**
- Available

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