Regulatory Affairs and Responsible Pharmacist

SUMMARY:
Regulatory Affairs and Responsible Pharmacist – Johannesburg

POSITION INFO:

Salary: R84,000 per month (CTC)

Our client, a highly reputable and well-established company in the pharmaceutical industry, is seeking a mature, experienced, and detail-oriented Regulatory Affairs and Responsible Pharmacist to join their team in Johannesburg.

Key Duties & Responsibilities

Company Compliance

• Ensure full compliance with SAPC, SAHPRA, and DOH legislation.
• Operate in line with the Medicines and Related Substances Control Act and Pharmacy Act.
• Manage printed packaging and promotional material compliance.
• Oversee Quality Management System including SOP implementation, updates, and audits.
• Coordinate with local laboratories for Post Importation Testing.
• Approve and release product batches for market in line with regulatory requirements.
• Maintain and update the Site Master File, SOPs, and Quality Manual.
• Prepare for and support SAPC/SAHPRA inspections.
• Ensure adequate training and documentation of staff competency.
• Review and approve batch manufacturing documentation prior to production.

Product Registration

• Compile, screen, and submit new registration applications to SAHPRA.
• Handle registration-related queries and maintain partner communication.
• Submit product variations and renewals as per SAHPRA requirements.
• Stay updated with local legislative changes and ensure ongoing compliance.
• Submit regulatory dossiers using Docubridge eCTD.

Documentation & Quality Management

• Manage the regulatory document control system.
• Ensure retention and availability of regulatory and quality records.

Pharmacovigilance

• Monitor and manage all adverse drug reactions across the group.
• Ensure timely receipt, review, and appropriate responses.

Reporting

• Provide weekly project updates to the CBDO and CEO.

Minimum Requirements

• BPharm Degree
• 5+ years'' experience in Regulatory Affairs
• Previous experience as a Responsible Pharmacist
• Proven experience in Quality Assurance

Behavioural & Technical Competencies

• High integrity, ethical, and confidential
• Accountability and ownership of compliance
• Strong leadership and interpersonal skills
• Excellent communication and planning ability
• Exceptional attention to detail
• Conscientious, cooperative, assertive, and deadline-driven

To Apply:

Please email the following to :

• Updated CV in Word format
• Copy of your ID
• Qualifications
• Reference letters or contactable referees
• A recent profile picture

📌 Only candidates who meet the minimum requirements will be contacted. If you have not heard from us within 2 weeks, please consider your application unsuccessful.

Join a leader in the pharmaceutical sector and take your compliance and regulatory career to the next level!