At a Glance
- Tasks: Ensure high-quality, compliant documentation for drug-device products and mentor team members.
- Company: Join a leading pharmaceutical CDMO with a commitment to sustainability and inclusivity.
- Benefits: Enjoy 28 days holiday, private medical insurance, and an 8% pension contribution.
- Other info: Flexible working arrangements and a supportive, diverse workplace culture.
- Why this job: Make a real impact in regulatory compliance while working on innovative medical devices.
- Qualifications: Degree in a scientific field and extensive regulatory experience in pharmaceuticals required.
The predicted salary is between 50000 - 59000 € per year.
Bespak are looking for a Regulatory Specialist for the Kings Lynn site, PE30 2JJ. The salary range for this permanent role is between £50k to £59k, plus a discretionary annual bonus. Our generous benefits package includes 28 days leave plus bank holidays, 8% company pension contribution to employees 3%, onsite parking and medical / dental / health / life assurance.
Working Pattern: Mon to Fri, 7.5 hours per day plus a 30 mins lunch break, between 8am and 5pm (8am to 4pm or 9am to 5pm). We can be flexible and look at what works for you within the needs of the business. In this hybrid role you would need to attend the Kings Lynn (PE30 2JJ) or Holmes Chapel (CW4 8BE) office at least 4 days each month, we are happy to discuss how this works best for you.
As a Regulatory Specialist, you will serve as a vital technical expert ensuring the delivery of high-quality, compliant documentation for complex drug-device combination products and chemical legislation. You will act as a primary point of escalation for Regulatory Associates, providing mentorship while reviewing and approving critical submissions such as technical files and DMFs. In this client-facing role, you will be providing strategic technical insight and leading internal projects to navigate evolving global standards and regulations. By managing regulatory intelligence and conducting impact assessments, you will guide the company through legislative changes while maintaining a steadfast commitment to product integrity and safety. Ultimately, you will be the authoritative voice for regulatory compliance, bridging the gap between intricate legal requirements and successful product development for our global customers.
As a Regulatory Specialist, your duties will include:
- Deliver high-quality and compliant documents to customers.
- Provide technical insight into regulations for various projects.
- Support technical aspects of drug device product development.
- Review and approve technical files and regulatory submissions.
- Act as an escalation point for complex regulatory questions.
- Mentor less experienced team members through training initiatives.
Preferred key skills and experience:
- Extensive regulatory experience in pharmaceutical sectors (Medical Devices).
- Degree-level education in a relevant scientific subject.
- Expertise in medical device standards.
- Proven ability to manage multiple projects and priorities.
- Professional communication skills for internal and external stakeholders.
- Proficient with EU and US regulatory filing procedures (Medical Devices).
Benefits:
- 28 days holiday + bank holidays
- 8% employer contribution added to employees 3%
- Private medical insurance
- Private dental insurance
- Permanent health insurance
- Group life assurance
- Free will service
- Well-being programme
- Employee Retail Discount Platform
- Recognition awards
- Free Parking
We are a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medications, including medical devices such as pressurised metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.
Kings Lynn is a market town steeped in history with an hourly direct rail link to Cambridge (1 hour) and London (2 hours). The location is close to the beautiful Norfolk coastline and is an hours drive to the cities of Norwich and Peterborough. The population is nearly 43,000 and offers various amenities, including supermarkets, a shopping centre, restaurants, 9 junior schools, 3 high schools, 5 GP practices, a hospital and College.
As an ethical employer we align our BZero sustainability initiative with our aim to be accredited to SBTI which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485.
Our core values are Customer Focussed, Respectful, Collaborative, and Agile these are woven into the fabric of our business and the values we measure ourselves by.
We are flexible. We understand that there is a life outside of work, so we aim to support you in attaining a happy work/life balance. To cater for employees individual circumstances, and where possible, we agree flexible working arrangements.
We value our inclusivity as we believe diversity should be embraced and celebrated. We live and work by these values and that is what makes our company a great place to work.
We are proud to be a disability positive employer. We will support you throughout the recruitment process with any adjustments you require therefore please contact the Recruitment Team if you require support.
By applying to this role, you are giving consent to Bespak Limited to process your personal data for employment/recruitment purposes only. All personal and sensitive data processed to Bespak is protected under GDPR regulations. To find out more about our privacy policy please visit our website or contact the local HR team.
Regulatory Specialist in Warrington employer: Bespak
Bespak is an exceptional employer located in Kings Lynn, offering a supportive and flexible work environment that prioritises employee well-being and professional growth. With a generous benefits package, including 28 days of leave, an 8% pension contribution, and a commitment to sustainability, we foster a culture of inclusivity and collaboration, making it a rewarding place for Regulatory Specialists to thrive in their careers.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in Warrington
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Bespak on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by brushing up on your regulatory knowledge. Make sure you can discuss recent changes in medical device regulations and how they impact product development. Show us you’re the expert we need!
✨Tip Number 3
Practice your communication skills! Since this role involves liaising with various stakeholders, being able to articulate complex regulatory concepts clearly is key. Try mock interviews with friends or use online resources.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Bespak.
We think you need these skills to ace Regulatory Specialist in Warrington
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your relevant experience in regulatory compliance and medical devices. We want to see how your skills align with the role of Regulatory Specialist, so don’t hold back!
Showcase Your Expertise:Use specific examples from your past work to demonstrate your knowledge of EU and US regulatory filing procedures. We love seeing candidates who can clearly articulate their understanding of complex regulations.
Be Professional Yet Personable:While we appreciate a professional tone, don’t be afraid to let your personality shine through. We’re looking for someone who can communicate effectively with both internal teams and external stakeholders, so show us your communication style!
Apply Through Our Website:Once you’re ready, make sure to apply through our company website. It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Bespak
✨Know Your Regulations
Make sure you brush up on the latest EU and US regulatory filing procedures, especially for medical devices. Being able to discuss specific regulations and how they apply to drug-device combination products will show that you're not just familiar with the basics but are truly invested in the role.
✨Showcase Your Mentorship Skills
As a Regulatory Specialist, you'll be expected to mentor less experienced team members. Prepare examples of how you've successfully guided others in the past. This could be through training initiatives or simply providing support during complex projects—demonstrating your leadership will set you apart.
✨Prepare for Technical Questions
Expect to face technical questions regarding the review and approval of regulatory submissions. Brush up on your knowledge of technical files and DMFs, and be ready to explain your thought process when tackling complex regulatory questions. This will highlight your expertise and problem-solving skills.
✨Align with Company Values
Familiarise yourself with the company's core values: Customer Focused, Respectful, Collaborative, and Agile. Think of examples from your past experiences that align with these values. Showing that you resonate with their culture will demonstrate that you're not just a fit for the role, but for the company as a whole.
