CMC Regulatory Affairs Specialist

Siemens Healthineers; Dunstable; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a CMC Regulatory Affairs Specialist to ensure compliance with UK and EU regulations. In this role, you will manage regulatory submissions and collaborate with teams to maintain product labels. Your expertise in regulatory CMC and strong communication skills will be crucial in supporting the development of innovative PET tracer technologies. Join a dedicated team committed to pioneering breakthroughs in healthcare and enjoy a comprehensive benefits package, including generous holiday and pension contributions. This is a fantastic opportunity to make a significant impact in the medical technology field.

Benefits

26 days' holiday

Up to 10% employer pension contribution

Share and bonus scheme

Private medical insurance

Dental cover

Paid volunteering days

Employee assistance programme

Qualifications

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

Responsibilities

• Ensure product compliance with UK, EU, and international regulations.
• Prepare CMC variations and renewal submissions under tight deadlines.

Skills

Regulatory CMC

Module 3 Writing

Analytical Skills

Communication Skills

Problem-solving

Education

Degree in Chemistry

Degree in Pharmacy

Degree in Life Science

Tools

DXC

eCTD Xpress

Veeva

Job description

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Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As part of Siemens Healthineers, PETNET 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 50 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 and renewal submissions under tight deadlines.
• Manage regulatory CMC and labelling submissions, focusing on EU/UK life cycle maintenance.
• Support development and upkeep of product labels and patient leaflets.
• Contribute to Regulatory Affairs strategy, including MRP, DCP, national submissions, and publishing.
• 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.
• Proficient in publishing tools (e.g., DXC, eCTD Xpress, Veeva), document management, and HA submission systems.
• Strategic, analytical, and problem-solving mindset.
• Excellent communication, teamwork, and time-management skills.
  
  

Benefits:

• 26 days' holiday with the option to buy or sell an additional 5
• 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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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing, Hospitals and Health Care, and Biotechnology Research

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