RA/CMC Specialist

ITH Icoserve; Greater London; On-site; GBP 80,000 - 100,000; Full time

Benefits offered by this job

26 days' holiday

Pension up to 10%

Share & bonus scheme

Private medical & dental

CSR volunteering days

Employee assistance programme

Job summary

Siemens Healthineers–Radiopharma International in London seeks a regulatory CMC professional to ensure UK/EU and global compliance, manage variations, and coordinate with cross-functional teams. You will review data, respond to health authority queries, and maintain lifecycle submissions.

Ideal candidates have 3–5 years in regulatory CMC, strong Module 3 expertise, and excellent communication and teamwork skills.

Qualifications

• Degree in Chemistry, Pharmacy, or related life science.
• 3–5 years’ experience in regulatory CMC, pharmaceutical, biotech, or related fields.
• Strong background in module 3 writing and regulatory CMC strategy development.
• Strategic, analytical, and problem-solving mindset.
• Excellent communication, teamwork, and time-management skills.

Responsibilities

• Ensure product compliance with UK, EU, and international regulations.
• Stay updated on relevant legislation and guidelines.
• Support EU regulatory team in response to health authority queries (e.g., MHRA).
• Prepare CMC variations under tight deadlines and manage regulatory CMC submissions, focusing on EU/UK life cycle maintenance.
• Evaluate scientific data for submissions and ensure compliance with corporate and local regulations.
• Review submissions for accuracy and consistency.
• Collaborate with EU regulatory team and maintain up-to-date system records.
• Build strong internal and external relationships and deliver on commitments.
• Strong communication and collaboration skills.

Job description

• Northwood - London City of - UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND

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 leading research organizations, pioneering new biomarkers and changing nuclear medicine for physicians and patients. With nearly 60 radiopharmaceutical distribution centres across the world, we are one of the largest PET biomarker producers globally. We are committed to developing innovative PET tracer technologies, thus helping to expand and advance the science of molecular imaging.

Your role:

• Ensure product compliance with UK, EU, and international regulations.
• Stay updated on relevant legislation and guidelines.
• Support EU regulatory team in response to health authority queries (e.g., MHRA).
• Prepare CMC variations under tight deadlines and manage regulatory CMC submissions, focusing on EU/UK life cycle maintenance.
• Evaluate scientific data for submissions and ensure compliance with corporate and local regulations.
• Review submissions for accuracy and consistency.
• Collaborate with EU regulatory team and maintain up-to-date system records.
• Build strong internal and external relationships and deliver on commitments.
• Strong communication and collaboration skills.

Your expertise:

• Degree in Chemistry, Pharmacy, or related life science.
• 3–5 years’ experience in regulatory CMC, pharmaceutical, biotech, or related fields.
• Strong background in module 3 writing and regulatory CMC strategy development.
• Strategic, analytical, and problem-solving mindset.
• Excellent communication, teamwork, and time-management skills.
• 26 days' holiday with the option to buy an additional 10
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme.

Who we are:

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in 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 are 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. Check our Careers Site at https://www.siemens-healthineers.com/en-uk/careers

Siemens Healthineers are proud to be a Disability Confident Committed employer. If you require any adjustments at any stage of the recruitment process, please let us know.

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