Location
Northwood

Hours
Full Time

Salary
Competitive salary package

About the Role
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As part of Siemens Healthineers, Radiopharma International is at the forefront of radiopharmaceuticals and molecular imaging. We work with some of the world’s leading research organizations, pioneering new biomarkers and changing nuclear medicine for physicians and patients. With nearly 60 radiopharmaceutical distribution centres worldwide, we are one of the largest PET biomarker producers globally. We are committed to developing innovative PET tracer technologies, helping to expand and advance the science of molecular imaging.

Your role will be to ensure product compliance with UK, EU, and international regulations. You will stay updated on relevant legislation and guidelines, support the EU regulatory team in responding to health authority queries such as those from MHRA, and prepare CMC variations under tight deadlines. Managing regulatory CMC submissions with a focus on EU/UK life cycle maintenance will be key. You will evaluate scientific data for submissions, ensure compliance with corporate and local regulations, review submissions for accuracy and consistency, collaborate closely with the EU regulatory team, and maintain up-to-date system records. Building strong internal and external relationships and delivering on commitments will be essential. Strong communication and collaboration skills are required to succeed in this role.

Benefits
26 days’ holiday with the option to buy an additional 10
Up to 10% employer pension contribution
Share and bonus scheme
Access to flexible benefits including private medical insurance and dental cover
Corporate Social Responsibility opportunities including 2 paid volunteering days per year
Support from our 24/7 employee assistance programme

Who we are
We are a team of more than 71,000 highly dedicated Healthineers in over 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients worldwide. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work
When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists who believe in each individual’s potential to contribute with diverse ideas. We come from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Experience
3-5 years’ experience in regulatory CMC, pharmaceutical, biotech, or related fields.
Strong background in module 3 writing and regulatory CMC strategy development.

About you
Strategic, analytical, and problem-solving mindset.
Excellent communication, teamwork, and time-management skills.
Ability to build strong internal and external relationships and deliver on commitments.

Qualifications
Degree in Chemistry, Pharmacy, or related life science discipline.