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
Please apply to response “at” [URL Removed] (no spaces when emailing) or call [Phone Number Removed]; to enquire.
Supporting documents to accompany CV:
Copy of ID
Copy of Bachelor of Pharmacy qualification
* SAPC Receipt and Certificate
Desired Skills:
- Average of 5 years Pharmaceutical industry experience
Desired Work Experience:
- 2 to 5 years
Desired Qualification Level & Accreditations:
- Degree
- South African Pharmacy Council