One of our clients in the Pharmaceutical Manufacturing industry is in need of a Deputy Pharmacist / Regulatory Pharmacist.

Purpose of the job:
To screen, request data, collate and compile the registration dossier, pre-registration and post-registration applications and where applicable any other documentation for submission to the Medicines Control Council or any other appropriate regulatory body as required.

Accountabilities:

1. Performs pre-launch stage product submission and registration activities

• Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s with different dosage forms, e.g. creams, tablets, etc. to the Medicines Control Council or any other applicable regulatory authority
• Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable first to market registrations
• Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are
followed after signing of supply / purchase / financial agreements

2. Performs dossier life cycle management registration activities

• Receives, prepares and submits all applicable updates, amendments, resolutions and any other correspondence required by the M.C.C. or any other applicable regulatory authority
• Completes dossier audits of Registered Products for the Therapeutic Category Portfolio assigned
• Conducts dossier due-diligences, post-registration amendments, pharmaceutical and analytical resolutions for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and in accordance with specified time-lines in order to support the business and strategic company objectives
• Conduct any applicable telephonic communication with M.C.C. or any other regulatory authority

3. Develops and manages stakeholder relationships

• Builds and pro-actively maintains critical relationships with the MCC and equivalent bodies in other countries to ensure streamlined submissions, evaluations and registrations
• Manages relationships with the MCC’s units to ensure more effective streamlining of the company’s applications when required

4. Administration duties and document maintenance, collection and delivery

• Ensures that the Dossier Room and Document Database is kept in good order by completing the required administration activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Ensures that photocopying, binding and final preparation of documents for submission to M.C.C. and in-house copies or any other applicable regulatory body are completed, and quality checked before final submission
• Completion of internal risk reports in line with the above submissions
• Delivery and collecting of documents to/from M.C.C. as and when applicable

Qualifications and Experience:

• B Pharm of Higher qualification (Post graduate degree)
• 2 – 3 years’ experience in regulatory affairs covering all areas of the function