Regulatory Manager (Pharma)

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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.

Once you click apply, you will be redirected to our company website to make your application.

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.

As a Regulatory Manager your duties will include:

• Be seen as an expert in either the drug or devise 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

Regulatory Manager, beneficial key skills and 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

Bespak Holmes Chapel is an Investors in People silver award winner who employs over 400 people and are a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medical products. Our products include medical devices such as pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.

Holmes Chapel is a beautiful village in Cheshire with excellent transport links via its railway station on the Crewe-Manchester Line. The village has a population of nearly 7,000 and offers various amenities, including supermarkets, shops, restaurants, schools, and a GP practice.

As an ethical employer we align our BZero sustainability initiative to the SBTI certification which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485.

A full job description can be downloaded on the application Screen.

Our core values are, Customer Focussed, Respectful, Collaborative, and Agile, these are woven into the fabric of our business and the values we measure ourselves by.

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.