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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: Collaborative environment with opportunities to grow your expertise in regulatory processes.
- Why this job: Make a real impact in the medical device industry while working from anywhere.
- 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 Watford 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 Watford
✨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 cheat sheet of key regulations and guidelines to help you articulate your expertise during discussions with potential employers.
✨Tip Number 3
Showcase your experience with specific projects in your conversations. When discussing your background, highlight any relevant work you've done with device verification, validation documents, or risk management to demonstrate your hands-on skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s a great way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged in their job search.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Watford
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 or pharmaceutical industry. 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 talk about 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 outcomes in device development.
✨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 not only interested in the role but also invested in the company’s mission.
✨Ask Insightful Questions
Prepare thoughtful questions about the team dynamics, ongoing projects, and the regulatory challenges they face. This not only demonstrates your interest but also gives you a chance to assess if the company culture and expectations align with your career goals.