Job Description

KEY RESPONSIBILITIES
Product registration

• Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required in neighbouring countries
• Compile and submit new registration applications, variations and renewals in neighbouring countries in line with South African dossiers.
• Conduct due diligence on received change controls, variation packages, and dossiers
• pertinent to, but not restricted to, lifecycle management of the assigned product portfolio in neighbouring countries
• Compile and submit responses to pre-registration recommendations, safety updates, renewals and variations, within agreed and specified time limits.
• Liaise with Regulators on behalf of the division on new and existing queries as and when required.
• Identify and maintain updates on existing products based on guidelines and allocated priorities in neighbouring countries
• Interact on a regular basis with PD departments, overseas affiliates, third parties and
• contractors on dossier related activities.
• Assist with the registration process and commercialisation of Complementary products in consumer portfolio
• Update the SAHPRA CAMS licence (3D-licence) when required - New CAMS products or changes to existing products
• Maintain the department's online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Regulations
• Interact with Third-Party Suppliers on dossier related activities (supplier meetings)
• Provide regulatory advice to internal and external stakeholders when required

Technical activities

• Assist department as a Power User (PU) for docuBridge, including, but not limited to, assisting with dB monthly report, validation errors, training, inclusion of new variations/products in dB monthly
• Compile and control permit process applications
• Assists with review of clinical questionnaires from Marketing department
• Manage and monitor the Change Control Process effectively

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as requested.

PRE-REQUISITES

• B. Pharm.
• Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance.

Skills Required