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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 that values respect and inclusivity.
- Why this job: Make a real impact on the future of inhalation therapies and sustainability.
- 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) employer: Bespak Limited
Contact Detail:
Bespak Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager (Pharma)
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or at events. We can’t stress enough how valuable personal connections are in landing that Regulatory Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of inhaled DDCs and regulatory strategies. We recommend practising common interview questions and having examples ready to showcase your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Regulatory Manager (Pharma)
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 specific requirements mentioned in the job description.
Showcase Your Expertise: Don’t hold back on showcasing your knowledge of regulatory documentation and your experience with Notified Body Opinions. We’re looking for someone who can confidently navigate the regulatory landscape, so make sure to include relevant examples from your past roles.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to explain your achievements and how they relate to the role. We appreciate a well-structured application that makes it easy for us to see your qualifications.
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 the role. Plus, you’ll find all the details you need about the position there!
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 serious about the position.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your expertise in regulatory documentation and problem-solving. Think about times you've successfully navigated complex regulatory challenges or delivered innovative solutions. This will help you stand out as a candidate who can bring real value to the team.
✨Build Rapport with Interviewers
Since this role involves working closely with customers, practice building rapport during your interview. Be friendly, approachable, and ready to engage in a two-way conversation. This will demonstrate your collaborative nature and ability to foster strong relationships, which is crucial for the job.
✨Prepare Thoughtful Questions
Have a few insightful questions ready to ask at the end of your interview. Inquire about the company's approach to sustainability in product development or how they support their employees in navigating regulatory changes. This shows your genuine interest in the role and the company’s values.