Regulatory Affairs Associate - Midrand, South Africa - Neoc_People
Description
PRINCIPLE DUTIES
- Studying and keeping up to date with changes in regulatory legislation and SAHPRA guidelines
- Gathering, evaluating, organising, managing and collating information in a variety of formats
- Ensuring compliance with regulations set by SAHPRA
- Maintaining familiarity with company product ranges
- Planning and assisting with regulatory inspections
- Assist with electronic document submissions (docuBridge)
- Providing productrelated information to manufacturers / printers / designers, if required
- Review documentation, under supervision of a pharmacist
- Assist with any administrative task required by Management. KNOWLEDGE REQUIRED
- Bachelors Degree
- Excellent computer literacy
- Post Basic Pharmacist Assistant Qualification
EXPERIENCE REQUIRED
Years Regulatory experience
- Electronic Document Management System (DocuBrigde) experience for eCTD essential
SKILLS REQUIRED
- Analytical skills
- Deadline Driven
- Problemsolving skills
- Presentation skills
- Excellent Interpersonal skills
- Strong Communication skills
- Detail oriented
- Can work well under pressure
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