Our client in the pharmaceutical industry is seeking an accomplished Senior Manager: Regulatory Affairs Strategy & Innovation to provide strategic regulatory leadership across innovative and complex medicine portfolios. The role will define regulatory pathways, evaluate scientific and benefit-risk evidence, lead regulatory authority engagement, and provide strategic input into development, registration, lifecycle, portfolio and business development decisions to support timely approvals and market access.

Key Responsibilities

• Develop and lead regulatory strategies for innovative and complex medicines, including NCEs, biologicals, biosimilars, complex generics, peptides, and advanced therapies.

• Critically assess clinical, non-clinical, safety, quality and benefit-risk evidence to support registrations, variations, waivers and lifecycle decisions.

• Provide regulatory intelligence and strategic guidance on SAHPRA requirements, reliance pathways, registration requirements, labelling and local documentation.

• Lead regulatory authority engagements, scientific advice interactions, query responses, clinical motivations, waiver requests and evidence-based regulatory justifications.

• Conduct regulatory due diligence for licensing, in-licensing, acquisitions, partnerships and new product opportunities, identifying data gaps, risks and appropriate market-entry pathways.

• Lead lifecycle regulatory strategy, including new indications, line extensions, post-approval variations and global-to-local alignment.

• Collaborate with Medical, Pharmacovigilance, Quality, R&D, Commercial, Supply Chain, Portfolio and global regulatory teams.

• Manage regulatory relationships with external partners, licensors, manufacturers, consultants and development teams.

Minimum Requirements

• Master’s Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medicine, Toxicology, Biotechnology, or a related scientific discipline.

• Minimum 10–12 years’ Regulatory Affairs experience, preferably across pharmaceutical, biological, specialty or complex product portfolios.

• At least 5 years’ experience in a strategic regulatory role involving complex product strategy, clinical data assessment, lifecycle management, authority engagement or regulatory due diligence.

• Proven experience with NCEs, biologicals, biosimilars and/or complex generics, including products supported by clinical data.

• Strong experience with clinical motivations, scientific justifications, waiver requests and regulatory authority query responses.

• Strong working knowledge of SAHPRA, ICH, EMA and WHO regulatory requirements, including direct experience engaging with SAHPRA.

• Demonstrated knowledge of CMC, Module 3, comparability, manufacturing site readiness and post-approval quality variations.

• Strong capability in clinical, non-clinical, quality and benefit-risk assessment.

• Proven experience in regulatory lifecycle management and working with cross-functional and external stakeholders.

• Advanced Regulatory Affairs qualification or certification advantageous.

Highly Advantageous Experience

• Advanced therapy medicinal products, cell and gene therapies, or highly specialised biological products.

• Clinical trial application strategy, protocol review, local bridging requirements and scientific advice.

• Market access, HTA, payer evidence, real-world evidence and launch sequencing.

• eCTD, regulatory information management systems, submission trackers and portfolio dashboards.

The ideal candidate is a highly strategic and scientifically grounded regulatory leader with exceptional judgement, critical thinking and business acumen. Strong influencing, negotiation and stakeholder management skills, together with the ability to navigate scientific and regulatory complexity, lead cross-functional teams and communicate evidence-based regulatory positions at senior level, are essential for success in this role. If you are an experienced Regulatory Affairs leader ready to shape regulatory strategy for innovative and complex medicines, apply now using the link below.