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- 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 medical devices 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 Manchester employer: Bespak
Contact Detail:
Bespak Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist in Manchester
✨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 brushing up on your regulatory knowledge. Familiarise yourself with the latest EU and US filing procedures. We recommend creating a cheat sheet of key regulations and standards to help you shine during those tricky questions.
✨Tip Number 3
Showcase your mentorship skills! If you’ve trained or guided others in your previous roles, make sure to highlight this in interviews. Companies like Bespak value collaboration and leadership, so let them know how you can contribute to their team.
✨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 genuinely interested in joining the team at Bespak. So, hit that apply button and let’s get you started on this exciting journey!
We think you need these skills to ace Regulatory Specialist in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Specialist role. Highlight your extensive regulatory experience in the pharmaceutical sector and any relevant qualifications. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory compliance and how you can contribute to our team. Be sure to mention your expertise in medical device standards and your ability to manage multiple projects.
Showcase Your Communication Skills: As a Regulatory Specialist, you'll need to communicate effectively with various stakeholders. In your application, give examples of how you've successfully navigated complex regulatory questions or mentored team members. We love seeing those professional communication skills in action!
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 your details directly, and we can't wait to see what you bring to the table!
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 EU and US regulatory filing procedures. Brush up on the latest medical device standards and be ready to discuss how you've navigated complex regulations in your previous roles.
✨Showcase Your Mentorship Skills
Since this role involves mentoring less experienced team members, prepare examples of how you've successfully guided others in the past. Highlight your communication skills and any training initiatives you've led to demonstrate your ability to support and develop your colleagues.
✨Prepare for Technical Questions
Expect to face technical questions related to drug-device combination products and compliance documentation. Review common challenges in the industry and think about how you would approach them. Being able to articulate your thought process will show your expertise and problem-solving abilities.
✨Align with Company Values
Familiarise yourself with Bespak's core values: Customer Focused, Respectful, Collaborative, and Agile. Think of examples from your experience that reflect these values and be prepared to discuss how you can contribute to their culture and mission during the interview.