Regulatory Affairs Pharmacist at Pharma Dynamics (Pty) Ltd

• Manage the registration process for allocated therapeutic categories for new and existing products, including liaison with SAHPRA and the relevant neighbouring countries Health Authorities and third parties.

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.

Job Requirements
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.