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Bespak

Regulatory Specialist

Holmes Chapel
Posted about 23 hours ago
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Regulatory Specialist – Holmes Chapel

Are you an experienced Regulatory professional looking to make a real impact? At Bespak, we're looking for a Regulatory Specialist to join our team at our Holmes Chapel headquarters and play a key role in bringing innovative healthcare products to market.

If you have at least three years' regulatory experience within the Medical Device, IVD, Combination Product or Pharmaceutical industry, particularly supporting New Product Introduction (NPI) programmes, we'd love to hear from you.

As a key member of our Regulatory team, you'll provide expert regulatory guidance throughout the business, supporting the design, development and commercialisation of new products. Working closely with internal teams, customers and external partners, you'll help shape regulatory strategies that ensure our products meet global compliance requirements while progressing successfully through development and into market.

This is an exciting opportunity for someone who enjoys collaborating across multiple departments, influencing key stakeholders and providing expert advice that drives innovation and compliance.

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What you'll be doing

As our Regulatory Specialist, you'll:

  • Develop and implement regulatory strategies for New Product Introduction (NPI) programmes.
  • Provide specialist regulatory advice and guidance across the business.
  • Support the design, development and commercialisation of pharmaceutical and combination products.
  • Work closely with customers, suppliers and cross-functional teams throughout the product development lifecycle.
  • Identify and interpret relevant regulatory requirements, standards and guidance, ensuring they are incorporated into development activities.
  • Prepare, maintain and support regulatory submissions, licences and registrations.
  • Ensure products remain compliant with applicable regulatory frameworks throughout their lifecycle.
  • Deliver regulatory awareness training and provide ongoing compliance support.
  • Monitor regulatory developments and undertake regular surveillance activities to keep the business informed of changing requirements.

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

About Bespak

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

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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 Positive 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.

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Skills

Regulatory Strategy
New Product Introduction (NPI)
Medical Device Compliance
IVD Regulations
Combination Product Regulations
Pharmaceutical Compliance
Regulatory Submissions
Licensing
Registration
Regulatory Surveillance
Stakeholder Management
Cross-functional Collaboration

Location

Holmes Chapel, England, United Kingdom

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