Regulatory strategy
Global and regional planning, product development advice and alignment of regulatory priorities with business objectives.
About BDH
Scientific depth. International perspective.
BDH Regulatory Consulting is led by a highly experienced regulatory affairs professional with a strong science background. That scientific foundation supports a disciplined approach to evidence, documentation and regulatory problem-solving.
The emphasis is on clear analysis, proportionate advice and practical outputs that clients can use—whether the task is a defined submission, a response to the TGA, a strategic question or additional support for an existing team.
Your consultant
Brian Hewitt, PhD
Independent regulatory consultant
Sydney, Australia
Brian Hewitt is an independent regulatory affairs consultant with more than 25 years of international pharmaceutical regulatory experience.
Before commencing consultancy in January 2026, Brian held senior roles at Pfizer, including Head of Regulatory Sciences for Australia, New Zealand and Korea. His leadership responsibilities in Australia and New Zealand encompassed new chemical entity submissions, product lifecycle management, clinical trial support and supply continuity. He worked closely with commercial, medical, drug safety, supply and quality colleagues, combining regulatory oversight with an understanding of business priorities.
Earlier roles included leading regulatory teams across Central and Eastern Europe, Africa and the Middle East, developing global regulatory strategies and strengthening agency engagement.
Brian served on the Medicines Australia Regulatory Affairs Working Group, contributing to improvements in the Australian regulatory environment through collaboration with the TGA and industry. His international contributions included the EFPIA EU Enlargement Regulatory Task Force and chairing the EFPIA Middle East Regulatory Network, alongside regulatory conference chairing and speaking roles.
Through BDH Regulatory Consulting, Brian brings this experience to strategic advice, submission support and regulatory leadership. His approach is scientifically grounded and pragmatic, with an emphasis on clear priorities, effective collaboration and work that clients can put into practice.
Skills and expertise
From strategy to delivery.
Experience spanning the product lifecycle and the teams responsible for bringing regulatory plans into practice.
Submissions and approvals
New chemical entity submissions, line extensions and management of submission and approval programmes.
Product lifecycle and supply
Post-approval regulatory work and coordination with Supply and Quality teams on continuity of supply.
Clinical trial support
Regulatory input to clinical development and collaboration with medical and development colleagues.
Agency and industry engagement
Service on the Medicines Australia Regulatory Affairs Working Group, collaboration with the TGA and industry on regulatory improvements, and international association and conference roles.
Leadership and cross-functional delivery
Team development, organisational change, budget oversight and collaboration across commercial, medical, safety, supply and quality functions.
Selected career history
Regional depth.
Global context.
Previous corporate roles inform Brian’s experience. BDH Regulatory Consulting operates independently.
Jan 2026–present
BDH Regulatory Consulting
Independent consultant
Sydney-based regulatory consultancy supporting pharmaceutical and biotechnology organisations.
Jan 2006–Dec 2025
Pfizer
Senior regulatory leadership
Career period including Head of Regulatory Sciences, Australia, New Zealand and Korea, Pfizer Biopharmaceuticals Group. Led the strategic direction, operations and performance of the ANZ Regulatory Affairs Department.
Jan 2001–Jan 2006
PGRD
Director & Head, Central East Europe & Africa Middle East Regulatory
Led regional regulatory teams supporting filings, approvals and business objectives; developed global regulatory strategies and strengthened agency engagement.
Aug 1998–Jan 2001
PGRD
Head, Central East Europe Regulatory
Built an international regulatory group supporting new product submissions in Central East Europe and represented Pfizer in trade association and regulatory agency initiatives.
Clear
Advice is expressed plainly, with the key issues and next steps made visible.
Rigorous
Scientific evidence and regulatory requirements are considered carefully and critically.
Practical
Recommendations remain grounded in the client’s context, priorities and deliverables.
Work with BDH