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 culture await you.
- 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 plus 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.
Regulatory Specialist in Chesterton 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 comprehensive benefits package, including generous leave, a robust pension scheme, and a commitment to sustainability, we foster a culture of inclusivity and collaboration, ensuring that every team member feels valued and empowered to excel in their roles. Join us to be part of a forward-thinking organisation dedicated to making a meaningful impact in the pharmaceutical sector while enjoying the rich history and amenities of Kings Lynn.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in Chesterton
✨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 regulations and how they impact drug-device products. Show them you're not just a candidate, but a future expert!
✨Tip Number 3
Practice your communication skills! Since this role involves client-facing interactions, being able to articulate complex regulatory concepts clearly is key. Try mock interviews with friends or use online resources to sharpen your pitch.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team at Bespak. Good luck!
We think you need these skills to ace Regulatory Specialist in Chesterton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Specialist role. Highlight your relevant experience in the pharmaceutical sector and any specific projects that showcase your expertise in medical device standards.
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 your passion for regulatory compliance and how your skills align with our core values at StudySmarter.
Showcase Your Communication Skills:As a Regulatory Specialist, you'll need to communicate effectively with various stakeholders. Make sure to highlight your professional communication skills in your application, especially any experience you have in client-facing roles.
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 to ensure we receive all your details correctly and can get back to you quickly!
How to prepare for a job interview at Bespak
✨Know Your Regulations
As a Regulatory Specialist, it's crucial to have a solid grasp of the relevant regulations and standards. Brush up on EU and US regulatory filing procedures, especially for medical devices. This knowledge will not only help you answer questions confidently but also demonstrate your expertise in the field.
✨Showcase Your Experience
Prepare to discuss your extensive regulatory experience in the pharmaceutical sector. Think of specific examples where you've successfully managed projects or mentored team members. This will highlight your ability to handle complex regulatory questions and showcase your leadership skills.
✨Communicate Effectively
Professional communication is key in this client-facing role. Practice articulating your thoughts clearly and concisely. Be ready to explain technical concepts in a way that’s easy to understand for non-experts, as this will reflect your ability to bridge the gap between legal requirements and product development.
✨Align with Company Values
Familiarise yourself with Bespak's core values: Customer Focused, Respectful, Collaborative, and Agile. During the interview, weave these values into your responses to show that you’re not just a fit for the role, but also for the company culture. This alignment can set you apart from other candidates.
