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- Tasks: Support regulatory affairs for innovative drug-device combination projects and collaborate with development teams.
- Company: Join a global leader in combination devices, working remotely with a dynamic team.
- Benefits: Competitive hourly rate, flexible remote work, and potential for contract extension.
- Other info: Work UK hours in a fast-paced environment with opportunities for professional growth.
- Why this job: Make a real impact in the medical device industry while advancing your regulatory expertise.
- Qualifications: Bachelor’s degree in a relevant field and experience in regulatory affairs.
The predicted salary is between 50 - 70 £ 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. The 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.
QUALIFICATIONS / SKILLS:
- 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 Coventry 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 Coventry
✨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 even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CMC and device requirements. We recommend creating a list of common interview questions related to regulatory affairs and practising your answers. Confidence is key!
✨Tip Number 3
Don’t forget to showcase your experience with technical documentation during interviews. Bring examples of your work or discuss specific projects where you provided regulatory support. This will help you stand out as a candidate who knows their stuff.
✨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 talented individuals like you, and applying directly can give you an edge over other candidates!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Coventry
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience with drug-device combination products and any relevant regulatory frameworks you've worked with. We want to see how your background fits perfectly with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills align with our needs. Don’t forget to mention specific projects or experiences that relate to the key duties outlined in the job description.
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience in supporting development projects and your knowledge of CMC and device requirements. We love seeing concrete examples of how you've contributed to similar roles in the past!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it’s super easy to do!
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 experienced but also up-to-date.
✨Prepare for Technical Questions
Expect to be asked about your experience with CMC and device requirements. Prepare examples from your past work where you successfully navigated complex regulatory challenges. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Show Your Team Spirit
This role involves collaboration with various teams, so be ready to discuss how you've worked effectively with others in the past. Highlight your communication skills and give examples of how you've contributed to team success, especially in cross-functional settings.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions prepared. Ask about the company's approach to regulatory challenges or how they support their teams in staying compliant. This shows your genuine interest in the role and helps you assess if it's the right fit for you.