Senior Manager: RA Strategy & Innovation

About the role

The client, a leading pharmaceutical company, seeks a Senior Manager to provide strategic regulatory leadership for innovative and complex medicine portfolios. You will shape regulatory pathways, assess benefit‑risk evidence and influence development, registration and market‑access decisions.

Key responsibilities

• Develop and lead regulatory strategies for NCEs, biologics, biosimilars, complex generics, peptides and advanced therapies.
• Critically assess clinical, non‑clinical, safety, quality and benefit‑risk data to support registrations, variations, waivers and lifecycle decisions.
• Provide regulatory intelligence on SAHPRA, reliance pathways, labeling and local documentation requirements.
• Lead engagements with regulatory authorities, scientific advice meetings, query responses and waiver requests.
• Conduct regulatory due diligence for licensing, in‑licensing, acquisitions and partnership opportunities.
• Collaborate with Medical, Pharmacovigilance, Quality, R&D, Commercial, Supply Chain and global regulatory teams.

Required profile

• Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medicine, Toxicology, Biotechnology or related field.
• 10–12 years of regulatory affairs experience, preferably with pharmaceutical, biological or complex product portfolios.
• At least 5 years in a strategic regulatory role covering product strategy, clinical data assessment, lifecycle management and authority engagement.
• Proven experience with NCEs, biologics, biosimilars or complex generics supported by clinical data.
• Strong knowledge of SAHPRA, ICH, EMA and WHO regulatory requirements and direct experience engaging with SAHPRA.

Required skills

• Regulatory strategy development and implementation.
• Regulatory intelligence and due‑diligence analysis.
• Clinical data assessment and benefit‑risk evaluation.
• CMC expertise (Module 3, comparability, site readiness, post‑approval variations).
• Engagement with regulatory authorities and scientific advice processes.