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- Tasks: Support regulatory affairs for innovative drug-device combination projects and ensure compliance with regulations.
- Company: Join a global leader in combination devices with a focus on innovation.
- Benefits: Competitive hourly rate, remote work flexibility, 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 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 Colchester 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 Colchester
✨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 or even referrals.
✨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 just apply anywhere; focus on companies that align with your career goals. Use our website to find roles that excite you and match your skills. Tailor your approach to each company’s culture and values.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share any additional thoughts you have about the role or how you can contribute to their team. It shows you're genuinely interested!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Colchester
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 the perfect fit for this role. Mention specific projects you've worked on that relate to device development and CMC support. We love seeing your passion and expertise come through in your writing.
Showcase Relevant Experience: In your application, be sure to showcase your experience in regulatory affairs, especially within the medical device and pharmaceutical industries. We’re keen on candidates who can demonstrate their understanding of regulations and guidelines, so don’t hold back!
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’re considered for the role. Plus, it makes the whole process smoother for everyone involved!
How to prepare for a job interview at LennTech Search
✨Know Your Regulations
Make sure you brush up on the latest regulations and guidelines governing pharmaceutical products and medical devices. Being able to discuss specific legislation and how it applies to drug-device combination products will show that you're not just familiar with the basics, but that you’re truly engaged with the field.
✨Showcase Your Experience
Prepare to discuss your previous roles in regulatory affairs, especially any experience with CMC and device-related documentation. Use specific examples from your past projects to illustrate your expertise and how you've contributed to successful regulatory submissions.
✨Understand the Company’s Needs
Research LennTech and their focus on combination devices. Tailor your responses to demonstrate how your skills align with their current projects and challenges. This shows that you’re proactive and genuinely interested in contributing to their team.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the company’s regulatory processes. This not only shows your interest but also gives you a chance to assess if the company is the right fit for you. Think about asking how they handle regulatory challenges or what their expectations are for the Senior Regulatory Affairs Specialist.