Senior Manager, Regulatory Affairs – Neuroscience
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
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
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.
Working pattern: Hybrid – 3 days per week on site (Tuesday–Thursday)
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