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Director, Regulatory Affairs Strategy – Cell Therapy
AstraZeneca. Contribute to and implement global regulatory strategy for a complex cell and gene therapy product or indication .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global regulatory strategy for cell and gene therapy products, with a strong focus on leading Health Authority interactions and managing complex regulatory submissions. Proven ability to mentor colleagues and enhance regulatory processes while adapting to dynamic project needs.
Highest-signal resume keywords
Global Regulatory StrategyHealth Authority InteractionsRegulatory Submission ManagementCell Therapy Regulatory ExperienceCross-Functional Team Leadership
ATS Keywords
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Hard Skills
Regulatory Strategy DevelopmentDrug/Biologic Development ProcessesRisk Assessment and MitigationRegulatory Dossier PreparationProduct Development in OncologyFDA Advisory Committee PreparationEMA Oral Explanation PreparationRegulatory Milestone DeliveryStakeholder ManagementProject Management
Soft Skills
Excellent Oral CommunicationStrong Written CommunicationPresentation SkillsOrganizational SkillsAdaptability
Industry Keywords
Cell TherapyGene TherapyPharmaceutical BusinessRegulatory AffairsComplex Development ProgramsEmerging Data AssessmentGlobal Dossier AssemblyCross-Functional Improvement ActivitiesBusiness Alliance EnvironmentTeam Development
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Contribute to and implement global regulatory strategy for a complex cell and gene therapy product or indication
- Support product maintenance activities
- Serve as regulatory lead for a product, indication, or defined program component
- Drive strategy and execution for Health Authority meetings, information-request responses, expedited pathway designations, and BLA development and submission
- Assess emerging data against program aspirations and communicate risks and mitigation plans to senior management
- Support delivery of project-related regulatory milestones, probability-of-success assessments, and mitigation strategies
- Lead preparation of regulatory strategy documents and target product labeling
- Support planning and assembly of the global dossier and core prescribing information
- Operate as a core member of Global Product and Global Regulatory Strategy Teams
- Participate in initiatives to enhance regulatory processes, tools, and practices
- Partner with country organizations and regional regulatory colleagues
- Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities
Requirements
What you’ll need- An advanced degree in a science related field
- Typically five to eight years of experience and/or appropriate knowledge/experience
- Understanding of global regulatory science and integration with program strategy
- Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
- Proven experience leading regulatory and cross-functional teams, and stakeholder management
- Ability to think strategically and critically and evaluate risks to regulatory activities
- Previous experience in leading Health Authority interactions in major markets
- Excellent oral, written, and presentation skills
- Strong organizational skills
- Ability to work in a fast-paced environment in a hands-on fashion
- Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
- Experience in cell therapy regulatory strategy or related regulatory activities
- Experience with product development in oncology, autoimmune, rare diseases, or neurology
- Experience supporting a global regulatory approval or major submission activity
- Experience with FDA advisory committee or EMA oral explanation preparation
- Experience working on due diligence activities or in a business alliance environment
- Experience mentoring colleagues or contributing to team development
- Contribution to non-project business initiatives or cross-functional improvement activities
Benefits
Comp & perks- Flexible working arrangements while balancing an expectation to work in the office
- Opportunities for growth and professional development
- Mentoring and matrix support
- Inclusive and diverse team environment
- Collaboration with globally connected teams
- Ideas heard, growth supported, and impact visible