Director of Regulatory Affairs

Director, Global Regulatory Affairs – Europe

Position Summar y
The Director, Global Regulatory Affairs – Europe provides strategic regulatory leadership for the development and lifecycle management of pharmaceutical products across the European region.

The role is responsible for developing and executing regulatory strategies that support clinical development, marketing authorisation applications, lifecycle management, regulatory governance and compliance, while ensuring alignment with global business objective s.

The Director will serve as the primary regulatory lead for assigned programmes within Europe, partnering closely with Global and Local Regulatory Affairs teams and broader cross-functional stakeholders.

The role will act as a key strategic interface with European competent authorities and represent the European regulatory perspective within Global Regulatory Affair s.
Key Responsibilit ies Regulatory Strat

• egy Develop and execute innovative regulatory strategies, including risk mitigation approaches, to support successful product development, registration and lifecycle management across Euro
• pe. Provide strategic regulatory guidance to cross-functional development teams from early development through to commercialisati
• on. Lead regulatory assessments of global development plans, identifying opportunities, risks and mitigation strategies while incorporating European regulatory consideratio
• ns. Ensure European regulatory strategies align with global regulatory objectives and business prioriti
• es. Provide strategic input on European regulatory priorities and regional requirements to inform global regulatory strategy and decision-maki
• ng. Provide regulatory input into due diligence, alliance management, business development and external partnership activities as requir ed.
  Regulatory Submissions & Lifecycle Manage
• ment Lead and coordinate the preparation and submission
• of: Marketing Authorisation Applications (M
• AAs)Scientific Advice requ
• ests Paediatric Investigation Plans (P
• IPs)Orphan Drug Designation applicat
• ions Variations, renewals and other post-approval submiss
• ions Provide strategic regulatory guidance across lifecycle activities, includ
• ing: Labelling upd
• ates Manufacturing cha
• ions New indicat
• ions Safety-related submiss
• ions Ensure submissions align with European legal and regulatory requirements and established development and submission timeli
• nes. Monitor regulatory commitments and ensure their timely complet ion.
  Health Authority Interac
• tions Serve as the primary regulatory representative with the EMA and European national competent authorities for assigned progra
• mmes. Develop briefing documents and lead cross-functional preparation for regulatory meetings, Scientific Advice procedures, oral explanations and inspect
• ions.

Communicate regulatory feedback and translate Health Authority expectations into strategic recommendations and actionable development plans aligned with global business object ives.
Cross-Functional Lead

• ership Partner with cross-functional teams to integrate regulatory strategy into overall product develo
• pment. Provide regulatory leadership during governance discussions and portfolio decision-m
• aking. Contribute to regulatory governance by ensuring clear decision-making, issue escalation and alignment between regional and global stakeho
• lders. Influence strategic decisions through strong scientific and regulatory expe rtise.
  Regulatory Intelligence & Com
• pliance Partner with Global Regulatory Intelligence to assess the impact of changes in European legislation, guidance, policy and Health Authority expect
• ations. Drive implementation of appropriate remediation strategies in collaboration with European and global stakeh
• olders. Translate regulatory policy and intelligence into practical recommendations for European and global
• teams. Ensure regulatory activities comply with applicable European regulations, company policies and quality sta
• ndards. Monitor and recommend updates to SOPs and work processes where required to ensure comp liance.
  Le
• adership Serve as an authorised signatory for regulatory and legal documents for the EU region and other designated
• regions. Manage and oversee direct reports, including priorities, expectations and development obj
• ectives. Mentor and develop regulatory professionals through both line-management and matrix str
• uctures. Support capability development across European Regulatory
• Affairs. Develop and maintain resource, capability and succession plans to support current and future portfolio requi
• rements. Contribute to process improvement and operational excellence init
• iatives. Foster a collaborative, patient-focused and inclusive culture.
  Quali fications

Education Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related scientific discipline

• required. Advanced degree such as an MS, Pharm D, Ph D or MD preferred.

Experience10+ years of progressive Regulatory Affairs experience within the pharmaceutical or biotechnolog

• y industry. Significant experience leading European drug development and marketing
• activities. Demonstrated experience leading complex regulatory strategies for innovative
• medicines. Experience working across global development programmes and leading cross-functi
• onal teams. Proven experience interacting directly with Health A
• uthorities. Experience supporting both development-stage and marketed products preferred.
  Knowledge
• & Skills Expert knowledge of European pharmaceutical regulations and regulato
• ry pathways. Strong understanding of global drug development, commercialisation and lifecycle
• management. Experience with ICH guidelines and EU pharmaceutical
• legislation. Strong scientific and technic
• al aptitude. Excellent strategic thinking and problem-sol
• ving skills. Strong written and verbal communication skills, with the ability to present effectively to senior stakeholders
• in English. Demonstrated ability to influence without direc
• t authority. Strong communication and negotiation skills, particularly when engaging with regulatory
• authorities. Strong project management and organisati
• onal skills. Ability to operate effectively within global, matrixed or
• ganisations. Proven leadership and talent development c
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