Senior Regulatory Affairs Pharmacist — CTD/eCTD Lead

Shift Pursuit; Johannesburg; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Shift Pursuit in Johannesburg is seeking an experienced Regulatory Affairs Pharmacist to lead compliance and submissions across the product lifecycle. This role demands strong SAHPRA relationships, deep regulatory knowledge, and the ability to drive timely CTD/eCTD registrations, renewals and variations.

You will review labeling, PI/PIL, and packaging; coordinate SAHPRA responses within deadlines; and mentor junior team members.

Qualifications

• Bachelor of Pharmacy (B.Pharm) required.
• 5+ years of regulatory affairs experience.
• Experience with CTD/eCTD submissions.
• Existing SAHPRA relationships and registrations (SAPC).

Responsibilities

• Lead regulatory compliance activities in line with SAHPRA legislation.
• Compile, review, and submit CTD/eCTD dossiers for registrations, renewals, and variations.
• Manage product lifecycle updates (PI/PIL, labeling, packaging).
• Coordinate responses to SAHPRA queries within timelines.
• Review promotional materials and artwork for compliance.
• Collaborate with cross-functional teams (Marketing, Manufacturing, Supply Chain, New Business).
• Mentor junior Regulatory Affairs team members and drive process improvements.
• Build and maintain strong working relationships with SAHPRA and stakeholders.

Skills

Regulatory affairs

CTD/eCTD submissions

SAHPRA liaison

Leadership/mentoring

Education

B.Pharm degree

Job description

Shift Pursuit in Johannesburg is seeking an experienced Regulatory Affairs Pharmacist to lead compliance and submissions across the product lifecycle. This role demands strong SAHPRA relationships, deep regulatory knowledge, and the ability to drive timely CTD/eCTD registrations, renewals and variations.

You will review labeling, PI/PIL, and packaging; coordinate SAHPRA responses within deadlines; and mentor junior team members.