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- Tasks: Shape regulatory strategy for innovative respiratory drug-device products.
- Company: Bespak, a leader in sustainable inhalation solutions.
- Benefits: Competitive salary, flexible work-life balance, and inclusive culture.
- Other info: Join a collaborative team committed to innovation and sustainability.
- Why this job: Make a real impact in the development of next-gen inhalation products.
- Qualifications: Experience with regulatory documentation and navigating complex approval processes.
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.
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 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.
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 Manager (Pharma) in London employer: Bespak Limited
Contact Detail:
Bespak Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager (Pharma) in London
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Regulatory Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of inhaled DDCs and regulatory strategies. We suggest practising common interview questions with a friend or in front of the mirror to boost your confidence.
✨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 seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Manager (Pharma) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Manager role. Highlight your experience with inhaled products and regulatory documentation, as well as any relevant skills like navigating NBOps or 510k processes. We want to see how your background aligns 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 strategy and how you can contribute to our mission of developing innovative inhalation products. Keep it engaging and personal – we love to see your personality!
Showcase Your Expertise: In your application, don’t shy away from showcasing your expertise in drug-device combination products. Mention specific projects or challenges you've tackled, especially those involving low GWP propellants or complex regulatory solutions. We’re looking for someone who can bring deep knowledge to our team!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you get all the updates directly. Plus, it’s super easy – just follow the prompts and let us know why you’d be a great fit!
How to prepare for a job interview at Bespak Limited
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations surrounding inhaled drug-device combination products. Familiarise yourself with Notified Body Opinions and low GWP propellants, as these are key topics for the role. Being able to discuss these confidently will show that you're not just a candidate, but a potential expert.
✨Showcase Your Communication Skills
Since you'll be advising clients and preparing presentations, practice articulating complex regulatory concepts in simple terms. Think about how you can demonstrate your ability to build strong relationships and guide customers through the approval process during the interview.
✨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 similar issues, especially those involving pMDIs, nasal sprays, or DPIs.
✨Align with Company Values
Familiarise yourself with Bespak's values like customer focus, respect, and collaboration. Be ready to share examples of how you've embodied these values in your previous roles. This will help you connect with the interviewers and show that you're a good cultural fit.