Senior Regulatory Affairs Pharmacist

Austell Pharmaceuticals; Johannesburg; Sur place; ZAR 900 000 - 1 300 000; Plein temps

Résumé du poste

Austell Pharmaceuticals in Parktown, Johannesburg is seeking a Senior Regulatory Affairs Pharmacist to lead regulatory submissions, manage product lifecycle, drive compliance, and mentor a growing team of regulatory professionals.

The ideal candidate will have a B.Pharm with SAPC registration, 5+ years in Regulatory Affairs, strong SAHPRA knowledge, and hands-on experience with CTD/eCTD submissions and DocuBridge.

Qualifications

• B.Pharm degree with current SAPC registration.
• Minimum 5 years' Regulatory Affairs experience in the pharmaceutical industry.
• Strong knowledge of SAHPRA requirements and CTD/eCTD submissions.
• Experience with regulatory document management systems (DocuBridge/eCTD or similar).
• Proven ability to independently manage regulatory submissions and authority interactions.
• Leadership or mentoring experience.
• Existing proven relationships with SAHPRA will be advantageous.

Responsabilités

• Lead regulatory submissions including CTD/eCTD dossiers, renewals, variations and transfers.
• Manage regulatory product lifecycle activities.
• Liaise with SAHPRA and coordinate responses to regulatory queries.
• Review promotional material, artwork and packaging for compliance.
• Support new product launches and business development initiatives.
• Mentor Regulatory Affairs team members.
• Drive continuous improvement of regulatory systems and processes.
• Collaborate across Marketing, Manufacturing, Supply Chain and Commercial teams.

Connaissances

Regulatory affairs expertise

Leadership

Mentoring

Cross-functional collaboration

Documentation management

Formation

B.Pharm degree

SAPC registration

Outils

DocuBridge

eCTD software

Description du poste

We're Hiring | Senior Regulatory Affairs Pharmacist

Parktown, Johannesburg | Full-Time | Office-Based

Are you an experienced Regulatory Affairs Pharmacist looking to take the next step in your career?

Austell Pharmaceuticals is looking for a highly motivated Senior Regulatory Affairs Pharmacist to join our Regulatory Affairs team. This is an exciting opportunity to play a strategic role in managing regulatory submissions, supporting new product launches, driving compliance, and mentoring a growing team of regulatory professionals.

What You'll Be Doing:

• Lead regulatory submissions including CTD/eCTD dossiers, renewals, variations and transfers


• Manage regulatory product lifecycle activities


• Liaise with SAHPRA and coordinate responses to regulatory queries


• Review promotional material, artwork and packaging for compliance


• Support new product launches and business development initiatives


• Mentor Regulatory Affairs team members


• Drive continuous improvement of regulatory systems and processes


• Collaborate across Marketing, Manufacturing, Supply Chain and Commercial teams.

What We're Looking For

• B.Pharm degree with current SAPC registration


• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry


• Strong knowledge of SAHPRA requirements and CTD/eCTD submissions


• Experience with regulatory document management systems (DocuBridge/eCTD or similar)


• Proven ability to independently manage regulatory submissions and authority interactions


• Leadership or mentoring experience


• Existing proven relationships with SAHPRA will be advantageous.

Why Join Austell?

At Austell Pharmaceuticals, you'll have the opportunity to work on a diverse product portfolio while contributing to meaningful healthcare solutions. We value collaboration, innovation, continuous improvement, and professional growth.