**Requirements**

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– Pharmacist degree & registered with the SAPC
– Minimum 5 years’ experience as a Regulatory Pharmacist and 1 exposure to Quality Assurance would be an added advantage.
– Medicine registration and CTD/eCTD training
– Regulatory experience and skill in the compilation, preparation, submission, maintenance of dossiers and new drug applications.
– Proficiency in one of South African languages is essential.
– Excellent written and verbal communication skills.
– Ability to manage multiple and varied tasks with enthusiasm and prioritization of workload with attention to detail.
– Computer literate with good numeracy skills.
– A flexible attitude with respect to work assignments and new learning.
– Self-motivated with a willingness to accept responsibility and challenges.

**Key responsibilities and accountabilities:**

Monitor and ensure compliance with regulatory guidelines and requirements. Stay updated with changes in regulations and assess the impact on the organization’s

Regulatory Pharmacist JD March 2026

products and processes and also provide guidance to internal stakeholders on compliance matters.

:

Involved in the development and review of product labelling and packaging materials to ensure compliance with regulatory requirements. Ensure that the information provided is accurate, clear, and in line with regulatory guidelines.

Collaborate with quality assurance teams to ensure that manufacturing processes and facilities comply with regulatory standards. May participate in audits and inspections to assess compliance and address any non-compliance issues from a regulatory perspective.

Involved in post-marketing surveillance and pharmacovigilance activities. Monitor and report adverse events, evaluate safety data, and ensure that appropriate actions are taken to protect patient safety.

Stay updated with the latest regulatory developments, guidelines, and best practices. Be able to analyze the impact of regulatory changes on the organization and provide recommendations for compliance.

In addition to these responsibilities, play a crucial role in strategic decision-making within pharmaceutical companies.

Provide regulatory expertise and guidance to support product development, registration, and commercialization strategies and assess the regulatory landscape and advise on potential risks and opportunities associated with regulatory requirements.

Overall, ensures that pharmaceutical products meet regulatory requirements, are safe and effective, and are available to patients in a timely manner.

Pay: R70 000,00 – R100 000,00 per month

Work Location: In person