Regulatory Affairs Pharmacist
| Location | Gauteng, South Africa |
| Date Posted | May 14, 2021 |
| Category |
Pharmacy
|
| Job Type |
Full-time
|
| Currency | ZAR |
Description
Multinational Pharmaceutical Industry, requires an experienced Regulatory Affairs Pharmacist.
Qualification and Experience Required, but not limited to:
Pharmacist degree (registered with the SAPC)
Minimum 2 years current Regulatory Affairs experience non negotiable
Average of 5 years Pharmaceutical industry experience
Expertise on new and emerging acts, regulations and guidelines in pharmaceutical industry
Demonstrable experience across the product development, commercialization and maintenance lifecycle
Ensure country specific regulatory approaches to support the approval and registration of clinical trial applications, new products, line extensions, major variations and lifecycle management
Familiarity of clinical trial methodologies ICH/GCP, FDA and local country regulations advantageous
Experience of the Marketing Code of Practice
Expertise of clinical trial and regulatory requirements as pertaining to human medicines
Ensure guidelines and regulations compliance is adhered
Liaise directly with Health Authorities and enhance good relationships
Liaise with clinical research project managers, ensure to understand clinical research programmes as required
Timely communication of any GCP breaches
Be responsible as the representative for the regulatory Team
Review and approve artwork as well as promotional material
Reference: RAPH - JHB - MK
Supporting documents to accompany CV:
* Copy of ID
* Copy of Bachelor of Pharmacy qualification
* SAPC Receipt and Certificate