Global Director Regulatory Affairs - Biopharma

Global Director Regulatory Affairs - Biosimilars / BiologicsWe are partnering with a leading global pharmaceutical organisation to appoint a Global Director Regulatory Affairs to play a critical role in shaping and driving worldwide regulatory strategy across an innovative biosimilars portfolio.This is a high-impact leadership position offering the opportunity to influence global development programmes, lead complex health authority interactions, and contribute directly to the expansion of life-changing biologic therapies across international markets.The RoleAs Global Director Regulatory Affairs, you will provide strategic regulatory leadership for biosimilar development and lifecycle management activities on a global scale. You will work cross-functionally with development, clinical, manufacturing, and commercial teams to ensure successful submissions, approvals, and post-approval regulatory activities worldwide.You will be responsible for:

• Leading global regulatory strategy for biosimilar and biologic products
• Driving regulatory submissions and lifecycle management activities across key international markets including EU and US
• Leading interactions with global health authorities including EMA and FDA
• Providing strategic input into development programmes and regulatory pathways
• Coordinating cross-functional dossier preparation and submission activities
• Supporting launch readiness activities and global expansion plans
• Managing regulatory risks while identifying pragmatic and commercially aligned solutions
• Mentoring and guiding regulatory team members and key stakeholders

Candidate ProfileWe are looking for an experienced regulatory affairs professional with strong expertise in biologics and/or biosimilars within a global pharmaceutical environment.Requirements include:

• Significant Regulatory Affairs experience within biologics or biosimilars
• Proven experience with global submissions including EU MAA and/or US BLA
• Strong understanding of biosimilar development and lifecycle management
• Experience leading interactions with regulatory agencies such as EMA and FDA
• Background working within complex global development programmes
• Strong strategic mindset with the ability to influence cross-functional stakeholders
• Excellent communication and leadership skills
• Degree in Life Sciences, Pharmacy, or related scientific discipline

Why Apply?This is an opportunity to join a highly innovative and internationally focused organisation at a pivotal stage of growth within the biologics and biosimilars space. You will have genuine strategic influence, global visibility, and the opportunity to work on products that improve patient access to critical therapies worldwide.

For a confidential discussion or to learn more, please apply directly or contact us for further information