Regulatory Affairs Pharmacist (1 year contract) Jhb
Location: Johannesburg
Sector: Pharmaceutical Industry
Essential: Experience Required
Reference: RAP – JHB – MK
Please Note: Experience is required
Our Pharmaceutical Industry client, requires an experienced RA Pharmacist for a 1 year contract position who will be responsible for completion of country specific regulatory approaches for the authorization and registration of: new products, clinical trials, major variations, line extensions, & lifecycle management
Qualification and Experience Required, but not limited to:
- Pharmacist Degree & South African Pharmacy Council registration
- Average of 3 years Regulatory Affairs experience in human medicines
- Proven experience across product development, commercialization, & maintenance lifecycle
- Experience on managing complex regulatory issues
- Ensure to meet deadlines timeously, & ensure cost & quality standards are adhered
- Expertise on new & emerging Acts, Regulations & guidelines pertaining to pharmaceutical industry sector
- Comprehension of clinical trial methodologies advantageous
- Comprehension of clinical trial & regulatory requirements relating to human medicines
- Experience of the Marketing Code of Practice
- Coordinate with clinical research Managers
- Create strong relations with local & sub-country associates for execution of registration strategies on product portfolios, new & existing products
- Create, improve & manage the relationships with health authorities & Boards of Health
- Comprehend local regulations & emerging trends in the regulatory environment
- Poses the ability to foresee barriers & recommend alternative methods in line with policies & procedures
- Prepare CTA submission documents for initial application & subsequent amendments, & maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries
- Timeously report GCP breaches, or actions taken for safety reasons
- Compile & submit various applications
- Coordinate regulatory activities associated with product approval
- Maintain licenses
- Maintain compliance adherence for company specific regulatory systems & databases
- Maintain compliance adherence of product artwork & promotional materials
- Represent the regulatory team at cross-functional meetings
As required represent company at the relevant industry trade association meetings
Please apply to response “at” [URL Removed] or call [Phone Number Removed]; to enquire.
RE: RAP-JHB-MK
Supporting documents to accompany CV:
Copy of ID
Copy of Bachelor of Pharmacy qualification
* SAPC Receipt and Certificate
Desired Skills:
- Average of 3 years Regulatory Affairs experience in human medicines
Desired Work Experience:
- 2 to 5 years
Desired Qualification Level & Accreditations:
- Diploma
- South African Pharmacy Council