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For Companies At a Glance
- Tasks: Shape and present regulatory strategies for innovative respiratory drug-device products.
- Company: Bespak, a leader in sustainable inhalation product development.
- Benefits: Flexible work-life balance, competitive salary, and inclusive culture.
- Other info: Join a collaborative team committed to innovation and inclusivity.
- Why this job: Make a real impact on the future of inhalation therapies.
- Qualifications: Expertise in regulatory documentation and experience with inhaled products.
The predicted salary is between 77000 - 77000 £ per year.
About the Role
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.
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
Key Skills & Experience
- 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
Benefits & Values
We are flexible and support a happy work/life balance. Our company values Customer Focused, Respectful, Collaborative, Agile and inclusivity. We are proud to be a Disability Confident employer, and we support applicants throughout the recruitment process with any adjustments needed.
Regulatory Manager (Pharma) in England employer: Bespak Limited
Contact Detail:
Bespak Limited 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 relationships in the regulatory field, especially for roles like Regulatory Manager.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of inhaled DDCs and low GWP propellants. We recommend creating a list of potential questions and practising your responses. Confidence is key!
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work with regulatory documentation and successful product approvals. We want to see how you’ve tackled complex problems in the past.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
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 strategy, especially in the context of inhaled drug-device combination products. We want to see how your skills align with the role, so don’t hold back!
Showcase Your Expertise: Don’t forget to mention your experience with Notified Body Opinions and low GWP propellants. We’re looking for someone who can navigate the regulatory landscape confidently, so let us know how you’ve tackled similar challenges in the past.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your key achievements and relevant experiences stand out without unnecessary fluff.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at Bespak. Plus, it’s super easy!
How to prepare for a job interview at Bespak Limited
✨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.
✨Showcase Your Communication Skills
Since this role involves advising clients and preparing presentations, practice articulating complex regulatory concepts in a clear and engaging way. Think about how you can demonstrate your ability to build strong relationships and guide customers through the regulatory landscape.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or client situations. Prepare examples from your past experience where you've successfully navigated complex problems or delivered innovative regulatory solutions. This will highlight your problem-solving skills and expertise.
✨Align with Company Values
Familiarise yourself with Bespak's values like customer focus, respect, and collaboration. Be ready to discuss how your personal values align with theirs and provide examples of how you've demonstrated these qualities in your previous roles. This will show that you're not just a fit for the role, but also for the company culture.