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- Tasks: Ensure product compliance with regulations and support the EU regulatory team.
- Company: Siemens Healthineers is a leader in medical technology, innovating for better patient outcomes.
- Benefits: Enjoy 26 days holiday, flexible benefits, and corporate social responsibility opportunities.
- Why this job: Join a diverse team pioneering breakthroughs in healthcare for everyone, everywhere.
- Qualifications: Degree in Chemistry or Pharmacy with 3-5 years in regulatory CMC required.
- Other info: Remote work options and a commitment to diversity and inclusion.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Join to apply for the CMC Regulatory Affairs Specialist role at Siemens Healthineers 1 week ago Be among the first 25 applicants Join to apply for the CMC Regulatory Affairs Specialist role at Siemens Healthineers Get AI-powered advice on this job and more exclusive features. 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. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. 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. 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CMC Regulatory Affairs Specialist employer: Siemens Healthineers
Contact Detail:
Siemens Healthineers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the latest UK and EU regulations related to CMC in the pharmaceutical industry. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals already working in regulatory affairs, especially those in the pharmaceutical or biotech sectors. Attend industry conferences or webinars to make connections and gain insights that could give you an edge during the application process.
✨Tip Number 3
Prepare to discuss specific examples of your experience with CMC submissions and regulatory compliance during interviews. Highlight any successful projects where you managed tight deadlines or collaborated with cross-functional teams, as these are key aspects of the role.
✨Tip Number 4
Showcase your proficiency with publishing tools like eCTD Xpress or Veeva by discussing any relevant projects or experiences. Being able to speak confidently about these tools can set you apart from other candidates who may not have hands-on experience.
We think you need these skills to ace CMC Regulatory Affairs Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the CMC Regulatory Affairs Specialist position. Understand the key responsibilities and required expertise, such as compliance with UK and EU regulations, and experience in regulatory CMC.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly in CMC. Emphasise your background in module 3 writing and any specific tools you are proficient in, like eCTD Xpress or Veeva.
Craft a Compelling Cover Letter: Write a cover letter that connects your skills and experiences directly to the job requirements. Mention your problem-solving mindset and how your previous roles have prepared you for this position at Siemens Healthineers.
Highlight Communication Skills: Since strong communication and collaboration skills are essential for this role, provide examples in your application that demonstrate your ability to work effectively within teams and manage relationships with stakeholders.
How to prepare for a job interview at Siemens Healthineers
✨Know Your Regulations
Familiarise yourself with UK, EU, and international regulations relevant to CMC. Be prepared to discuss how you have ensured product compliance in your previous roles.
✨Showcase Your Experience
Highlight your 3-5 years of experience in regulatory CMC. Prepare specific examples of your work with module 3 writing and regulatory strategy development to demonstrate your expertise.
✨Demonstrate Communication Skills
Since strong communication is key for this role, practice articulating complex regulatory concepts clearly. Be ready to explain how you've built relationships with internal and external stakeholders.
✨Prepare for Technical Questions
Expect questions about publishing tools like DXC, eCTD Xpress, and Veeva. Brush up on your knowledge of these systems and be ready to discuss how you've used them in past submissions.
