Job Description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product registration

• Submit dossiers and relevant amendments in neighboring countries.
• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of the assigned product portfolio in neighboring countries.
• Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required in neighboring countries.
• 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 neighboring countries.
• Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on dossier related activities.
• Compile and submit responses to pre-reg recommendations, Safety Updates and variations, within agreed and specified time limits.
• Maintain the departmentxe2x80x99s online apps (CCP database, docuBridge, AW app etc) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalize printed packaging components in submitted countries in line with Act 101 and the Marketing Code.

Technical / Compliance activities

• Assist with technical queries internally and with the guidance of line management, externally.
• Assists with review and approval of batch release documents as and when required.
• Assists with periodic internal audits.
• 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 or B.Sc. degree or equivalent scientific qualification.
• Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance.

Pharma Dynamics