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Bespak are looking is 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.
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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.
Regulatory Specialist, 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).
Regulatory Specialist, 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.
A full job description can be downloaded on the application screen.
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. xsngvjr
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