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Senior Director, Regulatory Affairs Strategy – Cell Therapy
AstraZeneca. Own the end-to-end global regulatory strategy for a high-complexity cell therapy program from current stage through BLA submission .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global regulatory strategy for complex cell therapy programs, with a strong focus on BLA submission and regulatory compliance. Proven ability to lead cross-functional teams, manage stakeholder relationships, and navigate regulatory landscapes in oncology, autoimmune, rare diseases, and neurology.
Highest-signal resume keywords
Global Regulatory StrategyCell Therapy Regulatory StrategyRegulatory Affairs LeadershipStakeholder ManagementFDA Advisory Committee Experience
ATS Keywords
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Hard Skills
Regulatory Strategy DevelopmentDrug/Biologic Development ProcessesTarget Product Labeling StrategyRegulatory Dossier ConstructionRisk Assessment and MitigationHealth Authority InteractionsRegulatory Deliverables OversightRegulatory Tools DevelopmentContingency PlanningRegulatory Compliance Activities
Soft Skills
Strategic ThinkingCritical EvaluationExcellent Communication SkillsOrganizational SkillsAdaptability
Industry Keywords
Cell TherapyOncologyAutoimmune DiseasesRare DiseasesNeurologyPharmaceutical BusinessRegulatory ScienceGlobal Product TeamsBLA SubmissionBusiness Alliance Environment
About the role
Key responsibilities & impact- Own the end-to-end global regulatory strategy for a high-complexity cell therapy program from current stage through BLA submission
- Serve as global regulatory lead for complex, multi-indication programs and, where relevant, provide regional leadership
- Lead strategy for agency meetings, information requests and expedited pathway designations
- Direct planning and construction of the global dossier and core prescribing information
- Own target product labeling strategy and negotiation readiness
- Represent Regulatory Affairs on Global Product Teams
- Shape development and commercialization plans and contribute to governance presentations
- Align regulatory objectives with clinical, CMC, safety and commercial strategies
- Assess emerging data against program aspirations and present risks, trade-offs and mitigations to senior leadership
- Oversee regulatory deliverables and milestones, including probability-of-success assessments and contingency planning
- Lead, coach, mentor and, as applicable, line-manage Global Regulatory Strategy Team members
- Build relationships with regulatory stakeholders and partner with country and regional regulatory teams
- Lead development of novel regulatory tools and technology
- Contribute to non-project initiatives that advance working practices and impact
- Maintain accountability for product maintenance and compliance activities associated with marketed brands
Requirements
What you’ll need- A bachelors degree in a science related field
- 7+ years of experience in the regulatory space
- Demonstrated success in cell therapy regulatory strategy
- Deep 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
- Experience with product development in oncology, autoimmune, rare diseases, and neurology
- 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 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 adapt to changing business needs and priorities
- Successful leadership of at least one global regulatory approval, including leading response team and labeling negotiations
- Experience with FDA advisory committee and/or EMA oral explanation
- Experience working on due diligence activities and in a business alliance environment
- Experience in leading and growing people through coaching or mentorship
- Contribution to non-project business initiatives
Benefits
Comp & perks- Flexible working arrangements with an expectation of working from the office a minimum of three days per week
- Inclusive and diverse workplace
- Autonomy to lead and support to grow
- Collaborative, empowered environment
- Coaching, mentoring and talent development opportunities
- Opportunity to lead and promote novel regulatory tools and technology
- Opportunity to work on non-project business initiatives