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Salary: R70k to R80k+, ctc p/m, plus bonus, negotiable
Location:
Our client - a leading pharma and CAMS products company, requires an RA pharmacist to direct and oversee their regulatory and compliance activities , in the role of Regulatory Affairs Pharmacist and Compliance Manager. You will be in charge of making sure that our pharmaceutical goods follow national and international regulatory requirements in this capacity. In addition to managing regulatory submissions, your responsibilities will also include ensuring that Quality Management Systems (QMS) comply with applicable regulations and maintaining compliance with SAHPRA and other authorities. This role is perfect for you if you have a strong background in compliance and regulatory affairs and a strong commitment to maintaining industry standards.
Advantage: English AND Afrikaans speaking (advantage, but not a requirement)
- Prepare, review, and submit regulatory documents and applications, including new product registrations, variations, renewals, and complementary medicine product lists to SAHPRA and other relevant authorities.
- Utilize DocuBridge or equivalent document management programs for eCTD submissions.
- Compile and respond to queries from SAHPRA or other regulatory bodies.
- Ensure QMS processes are effectively aligned with current regulatory requirements.
- Review and approve key documents such as manufacturing and packaging documents, product specifications, stability and validation protocols, and SOPs.
- Provide regulatory input and support for change controls, deviations, and CAPAs.
- Support product launches from a regulatory and compliance perspective.
Minimum Requirements:
- Bachelor's or master's degree in pharmacy or a closely related field.
- A minimum of 5 years of regulatory affairs experience in the pharmaceutical industry.
Advantageous:
- Experience in pharmacovigilance.
- Background in QA or manufacturing.
The salary is negotiable and can vary according to qualifications, years of experience, specific skills, and specific experience.
A salary range of R70k to R80k ctc p/m, plus an incentive bonus is envisaged for this position - negotiable to ensure top candidates.
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