Senior Regulatory Affairs Manager

Practicus; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Practicus is recruiting for a Senior Manager, Regulatory Affairs – Neuroscience to lead UK Regulatory Affairs for a global biopharmaceutical organisation, guiding strategy across the lifecycle from development through to product launches.

Based in the UK with a hybrid pattern, the role provides strategic regulatory direction, builds cross-functional partnerships, mentors a small team and oversees submissions with the MHRA.

Qualifications

• Strong knowledge of UK regulatory environment and MHRA submissions process
• Experience leading and developing people in Regulatory Affairs
• Proven ability to develop and implement regulatory strategies across product lifecycle
• Excellent understanding of regulatory compliance and risk management
• Strong influencing, diplomacy and stakeholder management skills
• Ability to work across international, cross-functional environments
• Excellent communication and presentation skills
• Proactive, accountable and collaborative approach

Responsibilities

• Lead UK regulatory strategy and tactical implementation across the product lifecycle.
• Act as primary Regulatory Affairs contact for the Neuroscience area, partnering with global, European and UK teams.
• Provide line management and development for a small team of Regulatory Affairs professionals.
• Oversee regulatory submissions and activities with robust strategies and timely execution.
• Build and maintain relationships with UK authorities and industry associations.
• Monitor UK regulatory landscape and provide regulatory intelligence and strategic advice.

Skills

UK regulatory

MHRA submissions

Line management

Regulatory strategy

Cross-functional collaboration

Job description

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)