Are you based in the United States? Select your country to see jobs specific to your location.
Location: Cape Town, Western Cape, Gauteng, Eastern Cape
An established pharmaceutical company has an opportunity for an experienced RA Pharmacist (5+ years of RA dossier compilation experience) to join their team.
This is an office-based position, but the company offers flexibility to work about 2 days per week from home.
You MUST be based in Cape Town though.
- 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
- About 5+ years Regulatory Affairs experience in pharmaceutical industry.
- Experience working with SAHPRA and other Regulatory Authorities
- 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.
Salary is negotiable and will be based on specific years of experience, specific regulatory experience, and specific qualifications.
A salary range of between R75,000 and R80,000 per month, plus incentive bonus, is envisaged for this position.
The number of jobs in each salary range for all:
Cape Town, Western Cape, Gauteng, Eastern Cape
#J-18808-Ljbffr