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Practicus

Senior Regulatory Affairs Manager

Maidenhead
£90k – £100k/yr
Posted 1 day ago
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Senior Manager, Regulatory Affairs – Neuroscience

Maidenhead, UK | Hybrid – 3 days per week (Tuesday–Thursday)

An exciting opportunity has arisen for a Senior Manager, Regulatory Affairs to join the UK Regulatory Affairs function of a leading global biopharmaceutical organisation, supporting its Neuroscience portfolio.

This is a key leadership role, acting as the primary Regulatory Affairs contact for the assigned therapeutic area and providing strategic regulatory direction across the product lifecycle.

The opportunity

You will:

  • Lead UK regulatory strategy and tactical implementation across the product lifecycle, from clinical development through to marketing authorisation, lifecycle management and product launches
  • Act as the primary Regulatory Affairs contact for the Neuroscience therapeutic area, partnering closely with global, European and UK cross-functional teams
  • Provide line management and development for a small team of Regulatory Affairs professionals
  • Oversee regulatory submissions and activities, ensuring robust strategies, timely submissions and effective implementation
  • Build and maintain strong relationships with UK regulatory authorities and relevant industry associations
  • Monitor the evolving UK regulatory landscape and provide regulatory intelligence and strategic advice to the business
  • Support product launches, acquisitions, divestitures and other business-critical initiatives
  • Ensure regulatory compliance across medicines, medical devices, clinical trials and paediatric requirements
  • Represent Regulatory Affairs on relevant affiliate committees and cross-functional initiatives
  • Deputise for senior UK Regulatory Affairs leadership when required
  • Drive process improvements, capability building and consistency across the Regulatory Affairs team

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What we're looking for

We are seeking an experienced pharmaceutical Regulatory Affairs professional with:

  • Strong knowledge of the UK regulatory environment and MHRA submissions process
  • Previous line management experience and a strong track record of developing people
  • Experience developing and implementing regulatory strategies across the product lifecycle
  • Excellent understanding of regulatory compliance and risk management
  • Strong influencing, diplomacy and stakeholder management skills
  • The ability to work effectively across international, cross-functional and matrix environments
  • Excellent communication and presentation skills
  • A proactive, accountable and collaborative approach
  • A relevant Life Sciences degree

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Why consider this opportunity?

This is an excellent opportunity to take a strategic leadership position within UK Regulatory Affairs, working across an important Neuroscience portfolio while developing people, influencing business strategy and engaging with senior internal and external stakeholders.

Location: Maidenhead, UK
Working pattern: Hybrid – 3 days per week on site (Tuesday–Thursday)
Level: Senior Manager
Therapeutic area: Neuroscience

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Location

Maidenhead, England, United Kingdom

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