Regulatory Affairs Pharmacist Midrand - South Africa
Specialist Search Recruitment
A leading pharmaceutical company has an opportunity for an experienced RA Pharmacist (2 years of RA dossier compilation experience) to join their team. 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. Minimum Requirements Bachelor of Pharmacy degree is essential Registration with the South African Pharmacy Council (SAPC) is essential Minimum of 2 years Regulatory Affairs experience in pharmaceutical industry . Experience working with SAHPRA and other Regulatory Authorities in Africa. Excellent spoken and written English . 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. Salary is negotiable and will be based on specific years of experience, specific regulatory experience, and specific qualifications. A salary range of between R65,000 and R80,000 per month, plus incentive bonus, is envisaged for this position.
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