Helen Barker PhD

Regulatory Affairs Practice – Europe

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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