Regulatory Responsible Pharmacist / Regulatory Affairs Pharmacist - Midrand

Xcaliber Staffing; Gauteng; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading medical equipment distributor in South Africa is seeking a Regulatory Responsible Pharmacist. This role involves managing distribution processes, ensuring compliance with medical regulations, and coordinating submissions to SAHPRA. Ideal candidates will have at least 5 years of experience and a BPharm degree. The company values regulatory affairs expertise and knowledge of industry regulations.

Qualifications

• Minimum of 5 years experience as a Regulatory Responsible Pharmacist.
• Registered with SAPC.
• In-depth knowledge of Regulations, Acts, and Guidelines.

Responsibilities

• Manage quality issues of the distribution processes.
• Coordinate and manage CTD dossiers submissions to SAHPRA.
• Ensure compliance with The Medicines and Related Substances Act.

Skills

Regulatory Affairs experience

Knowledge of Regulations, Acts, and Guidelines

Warehousing and Distribution experience

Education

BPharm

Matric

Job description

Introduction

Our client has a track record of nearly 3 decades in the medical industry!

They are a leading South African based distributor of high-quality medical consumables and equipment, working with professionals in both private practice and state health facilities.

Duties & Responsibilities

As their new Regulatory Responsible Pharmacist, here's what you'll do:

• Operationally be involved with all aspects of the distribution processes and quality issues of the total organization.
• Responsible for the coordination and management of review, updating, compilation and submission of CTD dossiers to SAHPRA.
• Overall responsibility to ensure that ALL operations are conducted according to the requirements of The Medicines and Related Substances Act (Act of [missing year]), as amended, and The Pharmacy Act (Act 53 of [missing year]), as amended, as well as in accordance with the requirements of any other related legislation including Medical Device Regulation.
• Ensure compliance with ISO standards applied (i.e., ISO [missing standard]).
• Act as a Responsible Pharmacist for the company, including the warehouse and the applicant; responsible to the Pharmacy Council for any act performed by or on behalf of the company.

Desired Experience & Qualification

What you will need:

• A minimum of 5 years experience as a Regulatory Responsible Pharmacist from the Pharmaceutical / Medical / FMCG Manufacturing industry.
• Matric plus BPharm.
• Registered with SAPC.
• Regulatory Affairs experience a must have.
• Warehousing and Distribution experience.
• In depth knowledge of Regulations, Acts, and Guidelines.
• SAHPRA experience a MUST HAVE!

Interested?

Start an AFFAIR with this company and apply now!