Regulatory Affairs Pharmacist at Sandoz

Role Requirements :

• Education: Bachelor of Pharmacy
• Languages: English
• Experience: Minimum 2 years in Regulatory Affairs

New Products – Submissions for registration:

• Compilation and submission of new registration applications to ZA HA in accordance with HA and Sandoz requirements.
• Timeous registration of all products in accordance with ZA HA and Sandoz requirements.

Product maintenance – Regulatory Compliance:

• Compilation and submission of Quality and Safety variations to ZA HA in accordance with HA and Sandoz requirements.
• Timeous approval of all variations to minimise supply challenges and ensure product compliance.

Special activities: Regulatory Intelligence

• Provide accurate information to satisfy the technical and information requirements of different departments internationally and locally, as well as other stakeholders timeously.
• Document and report on the relevant RA activities timeously.
• Provide and ensure a high level of service, both to our internal and external customers.
• Provide marketing support by review of promotional material and support to brand teams.
• Networks/ Liaison: Build and maintain good relationships within the local and global organization and key stakeholders, and to contribute to a positive company image.
• Corporate Governance: Take responsibility for corporate citizenship within the sphere of influence and control, and to adhere to the company’s governance policies.