CMC Regulatory Affairs Specialist

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.

To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.