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- Tasks: Shape and present regulatory strategies for innovative respiratory drug-device products.
- Company: Bespak, a leader in sustainable inhalation product development.
- Benefits: Competitive salary, flexible working arrangements, and a supportive work environment.
- Other info: Join a diverse team that values inclusivity and supports your career growth.
- Why this job: Make a real impact on the future of inhalation therapies while enjoying work-life balance.
- Qualifications: Experience in regulatory documentation and navigating complex regulatory landscapes.
The predicted salary is between 77000 - 77000 £ per year.
Bespak are looking for a Regulatory Manager for the Holmes Chapel site, CW4 8BE. The salary for this onsite role is £77,000. This is a key role with overall responsibility for shaping and presenting regulatory strategy for respiratory drug‑device combination products, from both a container closure and medicinal product perspective. We're looking for someone who can confidently navigate the regulatory landscape for inhaled DDCs, including next‑generation propellants and sustainability considerations.
You'll work closely with customers, building strong relationships and guiding them on the most efficient and compliant pathways to product approval. You'll also bring deep expertise in regulatory documentation for inhaled products, including experience with Notified Body Opinions and transitioning to low GWP propellants. If you're passionate about regulatory strategy and want to make an impact in the development of innovative, sustainable inhalation products, we'd love to hear from you.
Regulatory Manager duties- Be seen as an expert in either the drug or device aspects of drug combination product development
- Advise clients on contents and suitability of documentation provided by the customer including gap analysis
- Prepare and deliver presentations to customers
- Responsible for regulatory intelligence throughout the company including assessment of business impact
- Experience of NBOps, 510k, DMF's, MMA etc
- Competent user of SAP
- Experience of pMDIs, Nasal sprays and DPI's
- Previous experience of delivering novel regulatory solutions to complex problems
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's what makes our company a great place to work. We are proud to be a Disability Confident 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.
Strictly No Agencies – Our in‑house recruitment team manage all our vacancies.
Regulatory Manager (Pharma) in England employer: Bespak
Contact Detail:
Bespak Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager (Pharma) in England
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or at events. We can’t stress enough how important it is to build those connections; they might just lead you to your dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We recommend practising common interview questions and tailoring your answers to highlight your regulatory expertise in inhaled products.
✨Tip Number 3
Showcase your skills through real-life examples. When discussing your experience, focus on specific projects where you navigated complex regulatory landscapes. We want to see how you’ve made an impact!
✨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, we love hearing from passionate candidates who are ready to make a difference.
We think you need these skills to ace Regulatory Manager (Pharma) in England
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience with regulatory documentation and inhaled products. We want to see how your skills align with the role of Regulatory Manager, so don’t hold back on showcasing your expertise!
Showcase Your Passion: Let your enthusiasm for regulatory strategy shine through in your application. We’re looking for someone who’s genuinely excited about making an impact in the development of innovative, sustainable inhalation products, so share your motivation and vision!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure your key achievements and experiences are easy to spot. This will help us quickly see why you’d be a great fit!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at Bespak.
How to prepare for a job interview at Bespak
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines related to inhaled drug-device combination products. Familiarise yourself with Notified Body Opinions, 510k submissions, and low GWP propellants. Being able to discuss these topics confidently will show that you're the expert they need.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or client situations. Think about past experiences where you've navigated complex regulatory landscapes and be ready to share those stories. This will demonstrate your problem-solving skills and expertise.
✨Showcase Your Communication Skills
Since you'll be advising clients and preparing presentations, it's crucial to highlight your communication abilities. Practice explaining complex regulatory concepts in simple terms. This will help convey your capability to build strong relationships with customers and guide them effectively.
✨Emphasise Your Flexibility and Inclusivity Mindset
Bespak values work/life balance and inclusivity, so be sure to express your alignment with these values. Share examples of how you've adapted to different working environments or supported diverse teams in the past. This will resonate well with their company culture.