Senior Regulatory Affairs Specialist: Global Approvals

Placements24; Polokwane; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Private health insurance

Performance bonus

Retirement savings plan

Job summary

Placements24 in Polokwane, South Africa, seeks an experienced Senior Regulatory Affairs Specialist to lead registration strategies across global markets. You will prepare, review, and submit regulatory dossiers, and liaise with authorities to facilitate approvals.

The role requires strong analytical and communication skills with a proven CTD/ICH track record. The ideal candidate has 6+ years in regulatory affairs, depth in regulatory requirements for drug development, and the ability to drive

Qualifications

• Bachelor's or Master's degree in a scientific field (Pharmacy/ Chemistry/ Biology).
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory applications in key markets.
• In-depth knowledge of regulatory requirements for drug development and registration.
• Strong understanding of ICH guidelines and CTD format.
• Excellent written and verbal communication, negotiation and interpersonal skills.
• Ability to manage multiple projects and priorities under pressure.

Responsibilities

• Prepare and submit high-quality regulatory dossiers (e.g., CTD, ANDA, NDA) for new drug applications and variations.
• Interpret and apply national and international regulatory guidelines (SAHPRA, FDA, EMA, ICH).
• Liaise with health authorities during the review process, responding to queries and requests.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Review labeling, promotional materials, and other product-related documentation for compliance.
• Manage post-approval regulatory commitments and ensure ongoing compliance.
• Conduct regulatory intelligence activities to stay abreast of evolving requirements.
• Collaborate with cross-functional teams, including R&D, quality, manufacturing, and marketing.

Skills

Regulatory affairs

Global regulatory submissions

CTD/ICH knowledge

Stakeholder communication

Education

Bachelor's or Master's degree in Pharmacy/ Chemistry/ Biology

Tools

Regulatory information systems

Job description

Placements24 in Polokwane, South Africa, seeks an experienced Senior Regulatory Affairs Specialist to lead registration strategies across global markets. You will prepare, review, and submit regulatory dossiers, and liaise with authorities to facilitate approvals.

The role requires strong analytical and communication skills with a proven CTD/ICH track record. The ideal candidate has 6+ years in regulatory affairs, depth in regulatory requirements for drug development, and the ability to drive