Director of Regulatory Affairs

Meet Life Sciences; Deutschland; Vor Ort; EUR 180.000 - 240.000; Vollzeit

Zusammenfassung

Meet Life Sciences is seeking a Director of Global Regulatory Affairs – Europe to provide strategic regulatory leadership across the European region for development, registration and lifecycle management of pharmaceutical products.

You will partner with global and local teams, interact with European authorities, and lead cross-functional programs to shape regulatory strategies and approval timelines.

Qualifikationen

• Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related scientific discipline
• Advanced degree such as an MS, PharmD, PhD or MD

Aufgaben

• Develop and execute innovative regulatory strategies to support product development and lifecycle management across Europe
• Provide strategic regulatory guidance to cross-functional development teams from early development through to commercialization
• Lead regulatory assessments of global development plans, identifying opportunities, risks and mitigation strategies for Europe
• Ensure European regulatory strategies align with global regulatory objectives and business priorities
• Provide regulatory input into due diligence, alliance management, business development and external partnerships as required
• Lead preparation and submission activities for regulatory filings (MAAs, Scientific Advice, PIPs, Orphan Drug Designations, variations) and lifecycle submissions

Kenntnisse

Leadership

Regulatory strategy

Cross-functional collaboration

Communication

Project management

Ausbildung

Bachelor's in Life Sciences/Pharma/Medicine

Advanced degree (MS/PharmD/PhD/MD)

Jobbeschreibung

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

iesRegulatory Strat

• egyDevelop 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

• mentLead and coordinate the preparation and submission
• of:Marketing Authorisation Applications (M
• AAs)Scientific Advice requ
• estsPaediatric Investigation Plans (P
• IPs)Orphan Drug Designation applicat
• ionsVariations, renewals and other post-approval submiss
• ionsProvide strategic regulatory guidance across lifecycle activities, includ
• ing:Labelling upd
• atesManufacturing cha
• ionsNew indicat
• ionsSafety-related submiss
• ionsEnsure 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

• tionsServe 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

• ershipPartner 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

• pliancePartner 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

• adershipServe 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

• 
  EducationBachelor's degree in Life Sciences, Pharmacy, Medicine or a related scientific discipline
• required.Advanced degree such as an MS, PharmD, PhD 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

• & SkillsExpert 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