CMC Regulatory Affairs Specialist

Client:

Location:

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

92eef171208c

Job Views:

3

Posted:

18.04.2025

Expiry Date:

02.06.2025

Job Description:

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.

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.

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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