Regulatory Manager (Pharma)

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.

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.

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