OVERVIEW
FOCUS AREAS
Global Regulatory CMC leader with proven success driving approvals across complex key markets.
Global CMC strategy
Dossier development
Lifecycle management
Regulatory submissions
Interacting with global health authorities (FDA, EMA, PMDA, NMPA)
Authoring and leading regulatory submissions
Cross-functional leadership
Daniel leads global CMC strategy across small molecules, biologics and advanced therapies, helping sponsors compress timelines from development to approval in the US, EU and key international markets. With over a decade of expertise in Regulatory Affairs, he is known for aligning regulatory strategy with business objectives, resolving complex CMC risks, and delivering right-first-time submissions under pressure. His teams have guided multiple MAAs/BLAs/NDAs and significant post-approval changes to approval, including record-speed filings in South Korea and China that set new benchmarks for standard review.
Previously, Daniel served as Regulatory CMC Region Head, APAC at argenx, where he built and led the regional RA CMC function and acted as regulatory CMC lead for a first-in-class ultra-concentrated biologic formulation in Phase I. Earlier roles at Alexion, MSD, and PAREXEL broadened his expertise in submission strategy, agency engagement and global compliance.
How Daniel helps our clients
- Translates development plans into phase-appropriate CMC strategies and evidence plans that withstand agency scrutiny.
- Designs and authors CTD Modules 2/3 and end-to-end dossiers; orchestrates efficient review and Q&A cycles.
- De-risks comparability, control strategy, and tech transfer; structures PACMPs and complex variations for predictable approvals.
- Leads agency interactions (FDA, EMA, PMDA, NMPA, MFDS) to secure scientific advice, meeting outcomes and approvals.
- Builds scalable regulatory operating models (templates, playbooks, KPIs) so clients can execute at speed post-engagement.
Selected outcomes
- First-cycle approvals and accelerated reviews across the US/EU and Asia.
- Successful resolution of high-impact CMC issues (stability, specifications, process validation, site adds) without programme delays.
- Record-speed standard reviews in KR/CN through proactive evidence packages and early authority alignment.
Focus areas
- Phase-appropriate global CMC strategy & risk management
- Dossier development and authorship (CTD M2/M3; IND/CTA/IMPD; MAA/BLA/NDA)
- Lifecycle management: PACMPs, variations, tech transfer, post-approval changes
- Regulatory submissions & agency engagement (FDA, EMA, PMDA, NMPA, MFDS)
- Cross-functional leadership and regulatory operations design
-
EDUCATION:
- Bachelor of Science (Honours) in Pharmaceutical Science, Technological University Dublin
CERTIFICATIONS:
- PRINCE2® Practitioner Certification in Project Management – AXELOS Global Best Practice
- PRINCE2® Foundation Certification in Project Management – AXELOS Global Best Practice
- Internal Quality Management Systems Auditor – IRCA | International Register of Certificated Auditors
ASSOCIATIONS:
- The Organisation for Regulatory Affairs (TOPRA)
-
Argenx, Ghent, Belgium
Associate Director, Regulatory CMC Region Head APAC Jan – July 2025- Led a sub-team of direct reports, establishing clear regional regulatory objectives aligned with business priorities and ensuring the timely submission and approval of Clinical Trial Applications, BLAs, and post-approval variations.
Argenx, Ghent, Belgium
Senior Scientist, Global Regulatory CMC, Biologics 2022 – 2024- As the Asia Pacific Region Lead, took ownership of regulatory CMC strategy for the region, recruited, onboarded and led a team of direct reports to ensure timely submission and approval of Clinical Dossiers, BLA’s and post-approval changes.
Alexion, Dublin
Manager, Global Regulatory CMC Biologics 2020 – 2022- As the Global Regulatory CMC lead for a Recombinant Enzyme Replacement Therapy, crafted effective strategies to obtain approvals for Marketing Authorisation Applications, post-approval changes, and annual reports across EU, US, JP, APAC and LATAM.
- Served as the primary point of contact with FDA (CDER and CVM) for Agency interactions and liaised directly with FDA in telecons and meetings for all CMC queries related to Alexion’s BLA and NADA.
- Successfully led a cross functional project team to secure the first EMA and FDA approvals for biologic drug substance manufacturing at Alexion’s Athlone Manufacturing Facility.
- Navigated complex CMC challenges during the COVID-19 pandemic, prioritising and leading supply critical submissions which ensured uninterrupted supply to patients.
- Led the authoring of a phase I IMPD for a siRNA molecule.
- Developed regulatory CMC strategy for a novel small molecule entering Phase II
Merck Sharpe and Dohme, Dublin
Regulatory Affairs Specialist, CMC Vaccines 2019 – 2020- Led EMEA region CMC efforts for the Live Viral Vaccines portfolio, directing major CMC submission projects and developing robust regulatory strategies for post-approval changes.
- Successfully compiled eCTD baselines for UK submissions post-Brexit, demonstrating adaptability to evolving regulatory landscapes.
- Played a crucial role in maintaining patient supplies throughout the product lifecycle by collaborating strategically and effectively with Global CMC Regulatory Affairs Product Leads.
- Acted as a Regulatory CMC SME, supporting the interpretation of major regulatory requirements at EMEA regional level.