Strategic Regulatory Affairs Leader – Innovation & Lifecycle

PSM Personnel; Gauteng; On-site; ZAR 1,000,000 - 1,600,000; Full time

Job summary

PSM Personnel is seeking a Senior Manager: Regulatory Affairs Strategy & Innovation to provide strategic regulatory leadership across innovative medicine portfolios. The role defines pathways, evaluates evidence, and leads authority engagements to support timely approvals and market access.

You will collaborate across Medical, Quality, R&D and Commercial teams, oversee lifecycle strategy, and conduct regulatory due diligence for partnerships and new opportunities to drive global-to-local

Qualifications

• Master's degree in Pharmacy or related life science field.
• 10–12 years regulatory affairs experience in pharma.
• At least 5 years in a strategic regulatory role.
• Experience with NCEs, biologicals, biosimilars or complex generics.
• Strong SAHPRA, ICH, EMA, WHO knowledge and regulatory authority interactions.

Responsibilities

• Develop and lead regulatory strategies for innovative medicines including NCEs.
• Assess clinical, non-clinical, safety and benefit-risk evidence to support registrations and lifecycle decisions.
• Provide regulatory intelligence on SAHPRA requirements and local documentation.
• Lead regulatory authority engagements and scientific advice interactions.
• Conduct regulatory due diligence for licensing, partnerships and acquisitions.
• Lead lifecycle regulatory strategy for new indications and line extensions.
• Collaborate with Medical, Pharmacovigilance, Quality, R&D, Commercial, Supply Chain and global teams.
• Manage regulatory relationships with external partners and development teams.

Skills

Regulatory leadership

Strategic planning

Stakeholder management

Cross-functional collaboration

Regulatory intelligence

Lifecycle management

Clinical data assessment

Education

Master's Degree in Pharmacy

Tools

eCTD

Regulatory information management

Submission trackers

Portfolio dashboards

Job description

PSM Personnel is seeking a Senior Manager: Regulatory Affairs Strategy & Innovation to provide strategic regulatory leadership across innovative medicine portfolios. The role defines pathways, evaluates evidence, and leads authority engagements to support timely approvals and market access.

You will collaborate across Medical, Quality, R&D and Commercial teams, oversee lifecycle strategy, and conduct regulatory due diligence for partnerships and new opportunities to drive global-to-local