Regulatory Affairs Pharmacist Cape Town

Specialist Search Recruitment • Other • Cape Town, Oos-Kaap, Western Cape, South Africa • $200 - $300 / year • 4h ago

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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

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