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About the Role

Leads the development and implementation of the global regulatory strategy for complex and high-visibility Oncology Cell and Gene Therapy (CGT) products. This role involves team leadership, mentorship, and establishing external relationships with key regulatory stakeholders, aiming for efficient approvals with competitive labeling.

Responsibilities

Lead and own the development and implementation of the global regulatory strategy for a CGT product of high complexity, from current stage through BLA submission.
Serve in dual-role as GRL and regional RAD.
Ensure regulatory strategies deliver an efficient path to approval with competitive labeling.
Contribute to governance presentations.
Lead regulatory strategy for all health authority meetings, responses to information requests, BLA development and submission, and expedited pathway designations.
Maintain a strong working knowledge of relevant disease areas, including early- and late-stage multiple myeloma.
Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise.
Participate in coaching and performance feedback to members of your GRST.
Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice.
Accountable for all Regulatory activities and the delivery of all project-related regulatory milestones.
Assess the probability of regulatory success and mitigations.
Lead preparation of the regulatory strategy document and target product labeling.
Demonstrate strategic, leadership, and collaboration skills, contributing to effective cross-functional teamwork.
Lead, participate, and promote non-project functional or cross-functional initiatives.
Engage externally on corresponding topics as needed.
Lead the development of novel regulatory tools and technology.
Ensure appropriate planning and construction of the global dossier and core prescribing information.
Accountable for product maintenance and compliance activities associated with marketed brands.
Partner with marketing companies and regional regulatory affairs staff to influence developing views/guidance.
May have line management responsibilities in addition to matrixed supervisory, leadership, and mentoring roles.

Requirements

An advanced degree in a science related field and seven-ten years of experience and/or appropriate knowledge/experience.
Demonstrated success in cell and/or gene 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 for multiple myeloma.
Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
Experience in Oncology (small molecules & biologics) is preferred.
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 major Health Authority interactions.
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.
Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations.
Experience with FDA advisory committee and EMA oral explanation.
Experience developing products for the treatment of autoimmune conditions.
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 (e.g. at a portfolio or cross functional level).

Skills

Cell and Gene Therapy Regulatory Strategy
Global Regulatory Science
Drug/Biologic Development Processes
Product Development for Multiple Myeloma
Oncology (small molecules & biologics)
Regulatory Team Leadership
Cross-functional Team Leadership
Stakeholder Management
Strategic Thinking
Critical Evaluation
Risk Assessment
Health Authority Interactions
Oral Communication
Written Communication
Presentation Skills
Organizational Skills
Adaptability
Project Management
FDA Advisory Committee
EMA Oral Explanation
Due Diligence
Business Alliance
People Leadership
Coaching
Mentorship

Work Type

Hybrid

Experience Level

Senior Director
Seven-ten years of experience

Education Level

Advanced degree in a science related field

Salary/Compensations

$218,058.40 - $327,087.60

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program
Retirement contribution
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements.
Working with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide.
If this opportunity to drive transformative cell and gene therapies towards approval resonates, apply now to join us in bringing life-changing medicines to those who need them most.

Equal Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.