At a Glance
- Tasks: Ensure high-quality, compliant documentation for drug-device products and mentor team members.
- Company: Join Bespak, a leading pharmaceutical CDMO with a commitment to sustainability.
- Benefits: Enjoy 28 days holiday, private medical insurance, and an 8% pension contribution.
- Other info: Flexible working arrangements and a supportive, inclusive 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 King’s 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 DMF’s. 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 employee’s 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 pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves. King’s 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 hour’s 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 King's Lynn employer: Bespak
Bespak is an exceptional employer located in King's Lynn, offering a supportive work culture that prioritises employee well-being and professional growth. With a generous benefits package, including 28 days of leave, a robust pension scheme, and flexible working arrangements, we foster an environment where employees can thrive both personally and professionally. Our commitment to inclusivity and sustainability, alongside our core values of being customer-focused, respectful, collaborative, and agile, makes Bespak a rewarding place to build a meaningful career.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in King's Lynn
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and medical device sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching the company and its products. Familiarise yourself with their regulatory processes and recent news. This will help you showcase your knowledge and passion for the role, making you stand out as a candidate.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to regulatory compliance and project management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and demonstrate your expertise effectively.
✨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 King's Lynn
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Specialist role. Highlight your relevant experience in pharmaceutical sectors and any expertise in medical device standards to catch our eye!
Showcase Your Skills:We want to see your professional communication skills shine through! Use clear and concise language to demonstrate how you can manage multiple projects and priorities effectively.
Be Authentic:Let your personality come through in your application. We value collaboration and respect, so don’t hesitate to share your unique perspective and how it aligns with our core values.
Apply Through Our Website:Once you're ready, click apply and head over to our website to submit your application. It’s the best way for us to receive your details and get the ball rolling on your journey with us!
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 in the medical devices sector. Being able to discuss specific regulations and how they apply to drug-device combination products will show your expertise and readiness for 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 previous roles, highlighting your ability to communicate complex information clearly and effectively.
✨Prepare for Technical Questions
Expect to face technical questions regarding compliance and documentation. Review common challenges faced in regulatory submissions and think about how you would approach these issues. This will demonstrate your problem-solving skills and technical insight.
✨Align with Company Values
Familiarise yourself with Bespak's core values: Customer Focused, Respectful, Collaborative, and Agile. Be ready to discuss how your personal values align with theirs and provide examples of how you've embodied these principles in your work.
