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, generous pension contributions, and private health insurance.
- 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.
- 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.
- 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 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 are proud to be a disability positive employer.
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.
Strictly No Agencies - Our in-house recruitment team manage all our vacancies.
Locations
Regulatory Specialist and Senior Specialist in Cheshire, Warrington employer: Bespak
Bespak is an exceptional employer located in the historic market town of Kings Lynn, offering a supportive and flexible work environment that prioritises work-life balance. With a comprehensive benefits package including generous leave, a robust pension scheme, and opportunities for professional growth through mentorship, employees are empowered to thrive in their roles. Our commitment to sustainability and inclusivity, 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 and Senior Specialist in Cheshire, Warrington
✨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 at Bespak or other companies.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory knowledge. Familiarise yourself with the latest EU and US filing procedures, and be ready to discuss how you’ve navigated complex regulations in past roles. Show them you’re the go-to expert they need!
✨Tip Number 3
Don’t just apply and wait! Follow up on your application through our website. A quick email or message can show your enthusiasm and keep you on their radar. It’s all about making that personal connection!
✨Tip Number 4
Be ready to showcase your mentoring skills. As a Regulatory Specialist, you’ll be guiding less experienced team members. Prepare examples of how you’ve successfully trained or supported others in your previous roles to demonstrate your leadership potential.
We think you need these skills to ace Regulatory Specialist and Senior Specialist in Cheshire, 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, especially in the pharmaceutical sector. We want to see how your skills align with the role of Regulatory Specialist!
Showcase Your Expertise:Don’t hold back on showcasing your knowledge of medical device standards and regulatory filing procedures. We’re looking for someone who can bridge the gap between legal requirements and product development, so let us know how you can do that!
Be Clear and Concise:When writing your application, keep it clear and to the point. We appreciate well-structured documents that are easy to read, so make sure your key achievements and experiences stand out!
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
Make sure you brush up on the latest regulations and standards in the pharmaceutical and medical device sectors. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Mentorship Skills
Since this role involves mentoring less experienced team members, be prepared to share examples of how you've successfully guided others in the past. Highlighting your ability to support and develop talent will resonate well with the interviewers.
✨Prepare for Client-Facing Scenarios
As a Regulatory Specialist, you'll be interacting with clients. Think of scenarios where you've had to provide strategic insight or navigate complex questions. Practising how you would handle these situations can help you convey confidence during the interview.
✨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 from your experience that demonstrate these qualities in action.
