Are you an experienced Regulatory Affairs Pharmacist looking to take the next step in your career with a leading pharmaceutical organization? Our client is seeking a detail-oriented and compliant professional to manage and support product lifecycle submissions and maintain top-tier regulatory alignment across their portfolio.

Key Responsibilities

Ensure full compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act, and all applicable regulatory guidelines.
Compile, review, and maintain regulatory dossier submissions in CTD and eCTD formats.
Manage end-to-end product lifecycle activities, including variations, renewals, and maintenance of registered products.
Monitor changing regulatory frameworks and guidelines to ensure organizational practices remain aligned with national requirements.
Liaise effectively with regulatory authorities and internal cross-functional teams to facilitate smooth approval processes.

Requirements

B.Pharm degree.
Current and active registration with the South African Pharmacy Council (SAPC).
In-depth knowledge of SAHPRA requirements, CTD/eCTD submissions, and product lifecycle management.
Solid track record in pharmaceutical regulatory affairs and compliance.

Our client is offering a highly competitive salary for this role based on experience.

Contact Hire Resolve for your next career-changing move. Apply for this role today—contact Thomas Stacey at Hire Resolve or via LinkedIn. You can also visit the Hire Resolve website at hireresolve.us or email us your CV at Manufacturing@hireresolve.za.com.

Package & Remuneration

Market Related

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Need staff. Email us. clients@hireresolve.us

Key Responsibilities

Ensure full compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act, and all applicable regulatory guidelines.
Compile, review, and maintain regulatory dossier submissions in CTD and eCTD formats.
Manage end-to-end product lifecycle activities, including variations, renewals, and maintenance of registered products.
Monitor changing regulatory frameworks and guidelines to ensure organizational practices remain aligned with national requirements.
Liaise effectively with regulatory authorities and internal cross-functional teams to facilitate smooth approval processes.

Requirements

B.Pharm degree.
Current and active registration with the South African Pharmacy Council (SAPC).
In-depth knowledge of SAHPRA requirements, CTD/eCTD submissions, and product lifecycle management.
Solid track record in pharmaceutical regulatory affairs and compliance.