At a Glance
- Tasks: Ensure product compliance and manage regulatory submissions in a dynamic healthcare environment.
- Company: Join Siemens Healthineers, a leader in medical technology and innovation.
- Benefits: Enjoy 26 days holiday, flexible benefits, and a generous pension scheme.
- Other info: Be part of a diverse global team dedicated to improving patient outcomes.
- Why this job: Make a real impact in healthcare by pioneering breakthroughs in radiopharmaceuticals.
- Qualifications: Degree in Chemistry or related field with 3-5 years regulatory experience.
The predicted salary is between 46300 - 52800 £ per year.
- 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.
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.
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RA/CMC Specialist employer: ITH Icoserve
ITH Icoserve is an exceptional employer, offering a dynamic work environment in Oxford where innovation meets flexibility. With a strong emphasis on employee growth and development, we provide opportunities for personal and professional advancement while fostering a collaborative culture that values diverse perspectives. Join us to be part of a team that not only leads in global trade solutions but also prioritises your career journey.
StudySmarter Expert Advice🤫
We think this is how you could land RA/CMC Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like ITH Icoserve. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like ITH Icoserve.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like ITH Icoserve. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what ITH Icoserve is looking for. A tailored application can really make you stand out!
We think you need these skills to ace RA/CMC Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at ITH Icoserve!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show ITH Icoserve that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at ITH Icoserve!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At ITH Icoserve, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at ITH Icoserve
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at ITH Icoserve that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with ITH Icoserve’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
