RA Regulatory Affairs Pharmacist
Location: Cape Town, Western 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.
Responsibilities:
- 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.
- Review artwork relating to products ensuring that it is in compliance with all legal requirements.
- Check format and content compliance with the latest codes of conduct and regulations.
- Keep abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.
Minimum Requirements:
- Bachelor of Pharmacy degree is essential.
- Registration with the South African Pharmacy Council (SAPC) is essential.
- About 5+ years of Regulatory Affairs experience in the pharmaceutical industry.
- Experience working with SAHPRA and other Regulatory Authorities.
- Hardworking – able to multitask 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: 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.
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