Regulatory Affairs Pharmacist

1. Duties and responsibilities

The successful candidate will be, among others, responsible for;

1.1. Ensure that all product dossiers are kept secure and up to date according to the

MCAZ requirements.

1.2. Prepare documents for regulatory filings according to WHO and MCAZ

requirements.

1.3. Timeous filing of applications for registration and re-registration.

1.4. Liaise with principals to ensure all information required by regulatory authorities

is supplied.

1.5. Review all promotional material for compliance with the advertising guidelines

before submitting it to MCAZ for approval.

1.6. Provide regulatory support to Marketing for product launches and training

activities.

1.7. Ensure all persons and premises licenses are renewed on time, and all retention

fees for products are paid on time.

1.8. Ensure circulars and guideline changes are communicated promptly to principals

and affected departments.

1.9. Manage the Pharmacovigilance system for the company's products and ensure

that it complies with the MCAZ/WHO/EMA guidelines.

1.10. Carrying out audits for all packaging material suppliers.

1.11. Lead Technology Transfer for purchased dossiers and new products.

1.12. Ensure compliance with regulatory-related contractual obligations in agreements

1.13. Participating in Internal and external auditing and following up on action points.

2. Person Specifications

The ideal candidate should be analytical and proficient in all aspects of the Quality

Management Systems procedures, with the following qualifications and experience

2.1. A Bachelor of Pharmacy degree.

2.2. A minimum of three years' experience in a pharmaceutical manufacturing

environment.

2.3. Valid practising certificate from the Pharmacists Council of Zimbabwe (PCZ).

2.4. Substantial knowledge of Quality Management Systems as applicable in the

pharmaceutical industry (cGMP) and the associated regulatory bodies guiding

the pharmaceutical industry.

2.5. Exhibition of cutting-edge business communication skills at all levels