Senior Global Regulatory Affairs Leader - Pharma

Placements24; Sandton; On-site; ZAR 1,500,000 - 2,300,000; Full time

Benefits offered by this job

Executive salary

Healthcare benefits

Retirement plan

International travel

Professional development

Job summary

Placements24 in Sandton, Gauteng, is seeking a Senior Regulatory Affairs Manager to lead regulatory operations for a global pharmaceutical portfolio. Based in Sandton, you will shape regulatory strategy, oversee dossier preparation (CTD, ANDA, NDA), and ensure timely approvals with SAHPRA, FDA, EMA and other authorities.

You will manage a team, align R&D, manufacturing, and marketing on regulatory requirements, monitor landscape changes, and drive compliance across the product lifecycle.

Qualifications

• Advanced degree in a life sciences field (Pharmacy, Chemistry, Biology) is required.
• Proven track record in global regulatory strategies and submissions.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop and implement regulatory strategies for new and existing products.
• Lead preparation, compilation, and submission of regulatory dossiers (CTD, ANDA, NDA) to global authorities.
• Serve as primary contact for regulatory agencies and manage communications.
• Ensure compliance with FDA, EMA, SAHPRA, and other regulations.
• Monitor regulatory landscape changes affecting products and strategies.
• Collaborate with R&D, clinical operations, manufacturing, and marketing teams.
• Provide regulatory guidance throughout the product lifecycle.
• Oversee post-approval activities (supplements, variations, annual reports).
• Mentor and manage a team of regulatory professionals.
• Contribute to development of regulatory policies and procedures.

Skills

Regulatory strategy

Leadership

Stakeholder communication

Team management

Education

Master's or PhD in Pharmacy, Chemistry, Biology

Job description

Placements24 in Sandton, Gauteng, is seeking a Senior Regulatory Affairs Manager to lead regulatory operations for a global pharmaceutical portfolio. Based in Sandton, you will shape regulatory strategy, oversee dossier preparation (CTD, ANDA, NDA), and ensure timely approvals with SAHPRA, FDA, EMA and other authorities.

You will manage a team, align R&D, manufacturing, and marketing on regulatory requirements, monitor landscape changes, and drive compliance across the product lifecycle.