BACKGROUND
FOCUS AREAS
EXPERIENCE
Thirty years of regulatory experience in the life sciences industry including radiopharmaceuticals. Skilled in leading and empowering teams, managing complex projects, and navigating regulatory landscapes.
Radiopharmaceutical development
Shaping the regulatory landscape
Empowering teams
Simplifying complex regulatory landscapes into strategies and action
Blue Earth Diagnostics Ltd VP Global Regulatory Affairs
Blue Earth Therapeutics Regulatory Affairs Head
GSK, Consultant, Neuroscience
J&J, Consultant, Established Products
Amgen Snr Manager, Emerging Markets
Helen is passionate about regulatory affairs, particularly navigating the complex frameworks to achieve swift development of promising agents, enabling them to reach patients sooner – especially in the radiopharmaceutical space.
With commitment to advancing the field of radiopharmaceuticals, Helen strives to deliver solutions that improve patient outcomes and quality of life. She has successfully filed and obtained approvals for multiple products in various markets, and established strong relationships with regulatory agencies and key stakeholders.
As Chair of the Regulatory/Quality Working Group at Nuclear Medicine Europe, she collaborates with industry peers and experts to address the regulatory and quality challenges and opportunities in the nuclear medicine sector.
Before joining Eliquent, Helen worked as the Global Head of Regulatory at the radiopharmaceutical company Blue Earth developing diagnostic and therapeutic radiopharmaceuticals, where she worked closely with US FDA and EMA.
Before transitioning to radiopharmaceuticals, Helen worked as a regulatory consultant, partnering with companies of all sizes across various therapeutic areas including neurology and oncology, to devise regulatory strategies to achieve client’s goals.
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EDUCATION:
PhD Biochemistry, University of Southampton
BSc (Hons) Microbiology and Microbial Technology, University of Warwick
ASSOCIATIONS:
Nuclear Medicines Europe (NMEU), Chair, Regulatory/Quality Working Group, 2020-present
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Professional Experience:
- Blue Earth Diagnostics Ltd VP Global Regulatory Affairs
- Blue Earth Therapeutics Regulatory Affairs Head
- GSK, Consultant, Neuroscience
- J&J, Consultant, Established Products
- Amgen Snr Manager, Emerging Markets
Expertise:
- Recent experience of taking a molecule from due diligence, through clinical development and to NDA approval
- External facing influencer via industry bodies
- Clinical trials – EU, US, China
- Paediatrics – PIP applications, waivers, modifications, annual reports, PSPs
- New Product applications – US, EU Centralised, EU MRP/DCP, National
- Orphan Drug Designation request, breakthrough designation
- Post licensing experience
- NCEs, generics, small molecules, biologicals, radiopharmaceuticals
- Proven ability to apply regulatory strategies to new technologies and therapeutic areas
- Building and developing highly regarded teams
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