Regulatory Affairs EU Strategy Lead

Your new company
An exciting opportunity has arisen to join a leading global biotechnology organisation at the forefront of innovative therapies. We are seeking an experienced Senior Regulatory Affairs Strategy Lead to play a pivotal role in shaping and executing EU regulatory strategies across a diverse development portfolio.This position offers the opportunity to work on high-impact programmes, influencing regulatory strategy from early clinical development through to marketing authorisation and life cycle management.
Your new role
As a key member of the Regulatory Affairs team, you will provide strategic leadership for EU regulatory activities, partnering with global stakeholders to drive successful regulatory outcomes. You will be responsible for developing regulatory pathways, leading major submissions, managing interactions with European regulators, and ensuring regulatory excellence throughout the product life cycle.Key Responsibilities

• Develop and execute EU regulatory strategies that support global clinical development and life cycle management objectives.
• Collaborate closely with Global Regulatory Leads and cross-functional project teams to define optimal regulatory pathways.
• Lead and oversee the preparation, submission, and management of major EU regulatory filings, including:
• Clinical Trial Applications (CTAs)
• Paediatric Investigation Plans (PIPs)
• Scientific Advice procedures
• Marketing Authorisation Applications (MAAs)
• Variations and life cycle management submissions
• Identify regulatory risks proactively and develop effective mitigation strategies.
• Drive submission strategy, content planning, and timelines to ensure high-quality, compliant regulatory dossiers.
• Support the development and maintenance of EU product information and labelling strategy.
• Monitor evolving EMA and national health authority requirements and assess potential impacts on development programmes.
• Build and maintain productive relationships with regulatory authorities, including direct interaction with the EMA.
• Represent Regulatory Affairs within project teams, governance forums, and external stakeholder meetings.
• Ensure compliance with all relevant regulations, company policies, and industry standards.

What you'll need to succeed
We are looking for an experienced regulatory professional with a proven track record of delivering complex regulatory strategies within the pharmaceutical or biotechnology industry.Essential Requirements

• Degree in Life Sciences or a related scientific discipline.
• Significant experience within Regulatory Affairs, with a strong focus on regulatory strategy.
• Demonstrable expertise leading major EMA submissions and regulatory interactions.
• Proven experience preparing and delivering successful EU Marketing Authorisation Applications (MAAs).
• Deep understanding of EU regulatory frameworks, guidelines, and evolving health authority expectations.
• Strong leadership and stakeholder management capabilities.
• Ability to influence cross-functional teams and senior stakeholders globally.
• Excellent communication and presentation skills.
• Strategic mindset with strong analytical and problem-solving abilities.
• Ability to operate independently while managing multiple priorities in a fast-paced environment.

What you need to do now
For more information about this or any other Regulatory Affairs contract jobs, please apply to this advert.