Regulatory Affairs Pharmacist Midrand

Xcaliber Staffing; Gauteng; On-site; ZAR 300 000 - 600 000; Full time

Job summary

An established industry player in the medical sector is seeking a Regulatory Responsible Pharmacist to oversee compliance and quality in their distribution processes. This role is pivotal in ensuring that all operations meet the stringent requirements of relevant legislation, including the Medicines and Related Substances Act and ISO standards. The ideal candidate will bring at least 5 years of experience in regulatory affairs and a solid understanding of pharmaceutical regulations. Join a dynamic team where your expertise will contribute to the health sector's integrity and quality standards.

Qualifications

• 5+ years as a Regulatory Responsible Pharmacist in the Pharmaceutical/Medical/FMCG industry.
• In-depth knowledge of regulations and experience with SAHPRA.

Responsibilities

• Manage distribution processes and quality issues across the organization.
• Coordinate and submit CTD dossiers to SAHPRA.

Skills

Regulatory Affairs

Knowledge of Regulations and Acts

Warehousing and Distribution

Quality Management

Education

BPharm Registered with SAPC

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. They are looking for their next superstar Regulatory Responsible Pharmacist!

Duties & Responsibilities

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

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

Desired Experience & Qualification

What you will need:

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

Interested? Start an AFFAIR with this company and apply now!