Senior Regulatory Affairs Leader - Global Dossier Expert

Placements24; Bloemfontein; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Paid leave

Bonuses

Training programs

Bloemfontein team culture

Job summary

Placements24 in Bloemfontein, SA, seeks a Senior Regulatory Affairs Manager to lead regulatory strategy and global submissions. Based in the Free State office, you will develop submission plans, interact with health authorities, and guide cross-functional teams through registrations and lifecycle management.

The ideal candidate has 7+ years in regulatory affairs, a relevant science degree, strong leadership, and excellent communication.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 7+ years of regulatory affairs experience in pharma/biotech.
• Experience preparing NDAs and variations; knowledge of FDA/EMA/SAHPRA/ICH.

Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers to health authorities worldwide.
• Act as primary contact for regulatory agencies and manage inquiries.
• Ensure compliance with local and international regulations, guidelines, and standards.
• Provide regulatory input to cross-functional teams (R&D, clinical, manufacturing, marketing).
• Lead regulatory documentation management and contribute to global policies and procedures.
• Mentor junior regulatory staff; participate in inspections and audits.

Skills

Leadership

Regulatory affairs

Communication

Analytical thinking

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related field

Job description

Placements24 in Bloemfontein, SA, seeks a Senior Regulatory Affairs Manager to lead regulatory strategy and global submissions. Based in the Free State office, you will develop submission plans, interact with health authorities, and guide cross-functional teams through registrations and lifecycle management.

The ideal candidate has 7+ years in regulatory affairs, a relevant science degree, strong leadership, and excellent communication.