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- Tasks: Support regulatory affairs for innovative drug-device combination projects and ensure compliance.
- Company: Join a global leader in combination devices with a focus on innovation.
- Benefits: Competitive hourly rate, remote work, and potential for contract extension.
- Other info: Work UK hours in a dynamic environment with opportunities for professional growth.
- Why this job: Make a real impact in the medical device industry while working on cutting-edge projects.
- Qualifications: Bachelor’s degree in a relevant field and experience in regulatory affairs.
The predicted salary is between 40 - 50 £ per hour.
LennTech are supporting a global combination devices client who have a need for a Senior Regulatory Affairs professional to come on board for an initial six-month hourly rate contract with a view to extending.
Person will be experienced in supporting development projects and has worked on drug device combination products and has knowledge of CMC and Device requirements.
KEY DUTIES:- Regulatory support to Device Development (DD) team and activities e.g. final review, comment and approval of existing device-related technical documentation including device verification and validation documents, device specifications, risk management, human factors, biological evaluation, device labelling, IFU/QRG, End of Phase review and advising on interpretation of legislation/guidance, attending internal device development meetings.
- Regulatory CMC support to Pharmaceutical Development (PD) team e.g. final review, comment and approval of pharm dev protocols and reports (pharm dev and stability), SPECs (bulk, final product, per strength), justifications of specs, shelf life justifications, QTPP, batch manufacture documents, Product History File, Technical Risk Assessments, Product Specification File, Product Specification Index, QTAs, labelling and packaging text, advising on interpretation of legislation/guidance, attending internal CMC meetings.
- Review of CCRs raised by other functions (e.g. assessment of impact on regulatory submissions and approval of CCRs).
- Review of Device and CMC related information in Clinical Documents: Clinical Protocol, Pharmacy Manual, Investigator’s Brochure.
- Reviewing and supporting CMC and Device sections of the Clinical Trial Notification in Australia.
- Bachelor’s Degree (or higher) in a relevant scientific or engineering field.
- Experience in regulatory affairs within the medical device, CMC or Drug-Device combination product industry, preferably from pharmaceutical industry or from a regulatory agency.
- Demonstrated understanding of and ability to interpret regulations and guidelines governing pharmaceutical products and medical devices.
- Strong knowledge of regulatory submission processes and global regulatory frameworks.
Please note this role will be UK hours. Feel free to reach out and discuss further.
Senior Regulatory Affairs Specialist in Warrington employer: LennTech Search
Contact Detail:
LennTech Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Warrington
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with drug-device combination products. A friendly chat can lead to insider info about job openings that might not be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC and device requirements. Be ready to discuss specific projects you've worked on and how you navigated regulatory challenges. We want to see your expertise shine!
✨Tip Number 3
Don’t forget to showcase your soft skills! Communication is key in regulatory affairs, so be prepared to demonstrate how you effectively collaborate with cross-functional teams. We love seeing candidates who can bridge the gap between technical and non-technical folks.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Regulatory Affairs Specialist role. We’re always on the lookout for top talent, and applying directly shows your enthusiasm for joining our team!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Warrington
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in regulatory affairs, especially with drug-device combination products. We want to see how your background aligns with the key duties mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that relate to the responsibilities outlined, like your work with CMC and device requirements.
Showcase Relevant Skills: Don’t forget to emphasise your understanding of regulations and guidelines in your application. We’re looking for someone who can interpret legislation effectively, so make that clear in your written materials.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding your application status.
How to prepare for a job interview at LennTech Search
✨Know Your Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially around drug-device combination products. Familiarise yourself with the specific regulations and guidelines that govern these areas, as well as any recent changes in legislation. This will show that you're not just qualified but also genuinely interested in the field.
✨Prepare for Technical Questions
Expect to be asked about your experience with device verification, validation documents, and CMC requirements. Prepare specific examples from your past work that demonstrate your expertise in these areas. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Show Your Team Spirit
Since this role involves collaboration with various teams, be ready to discuss how you've worked with cross-functional teams in the past. Highlight your communication skills and how you’ve contributed to team success, especially in internal meetings or project discussions.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to regulatory challenges or how they support their teams in staying updated with regulations. This shows your enthusiasm for the role and helps you gauge if the company is the right fit for you.