Our client inthe Medical industry is looking for a Regulatory Affairs Pharmacist to join their organisation.
Salary: Market Related
- Compile and submit new product applications and ensure that the registration requirements are fulfilled so that the registration process and approval can be obtained as soon as possible.
- Monitor and follow up on the progress of submissions.
- Activities relating to product lifecycle management.
- Maintain and develop working relationships effectively and provide required regulatory support.
- Reviewing artwork relating to products ensuring that it is in compliance with all legal requirements.
- Checking Format and Content Compliance with latest codes of conduct and regulations.
- Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.
- Bachelor of Pharmacy degree is essential
- Registration with the South African Pharmacy Council (SAPC) is essential
- Minimum of 2-4 years Regulatory Affairs experience in pharmaceutical industry.
- Experience working with SAHPRA and other Regulatory Authorities in Africa.
- Experience submitting eCTD – good computer literacy skills also required.
- Hard working – able to multi task and manage multiple projects simultaneously.
- Strong communication skills – experience in liaising with Business Managers, Quality Assurance & Marketing departments
- Knowledge of Acts, Regulations and guidelines pertaining to the Pharmaceutical Industry.
- In-depth knowledge of regulatory requirements.
- Understanding of regulatory compliance and the impact this can have on the business.
- Good Understanding of Quality Management Systems, SAHPRA Guidelines and Policies, Medicines and Related substances and regulations, GMP and any other QA/RA related guidelines.
Basic Salary: Market Related
Medical Aid Company Contribution
Pension Fund Company Contribution
- Regulatory Affairs Pharmacist
- Bachelor of Pharmacy degree
- Regulatory Affairs
Desired Work Experience:
- 2 to 5 years
Desired Qualification Level:
About The Employer:
Our client is based in North Riding
Employer & Job Benefits:
- Medical Aid
- Pension Fund