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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 may involve serving as a Franchise Global Regulatory Lead (GRL) on complex programs and potentially functioning as a regional lead. The Senior Director ensures regulatory strategies facilitate efficient approvals with competitive labeling, aligning with product characteristics and business, market, and patient needs. They provide team leadership, coaching, and mentorship to the CGT Global Regulatory Strategy Team, driving global regulatory deliverables in line with Global Product Team (GPT) goals. The role also involves establishing and leveraging external relationships with key regulatory stakeholders to maintain a competitive advantage, positioning the incumbent as a senior leader within the regulatory community.

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.
May serve in dual-role as GRL and regional RAD.
As a core member of the global product team, ensure that regulatory strategies are designed to deliver an efficient path to approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients, and contribute to governance presentations.
Lead regulatory strategy for all health authority meetings, responses to information requests, BLA development and submission, expedited pathway designations.
Maintain a strong working knowledge of the relevant disease areas: early- and late-stage multiple myeloma.
Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
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 and accountable for all Regulatory activities.
Accountable for the delivery of all project-related regulatory milestones, including assessment of 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 in product development.
Lead, participate, and promote non-project functional or cross-functional initiatives and engage externally on the 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 led by the respective teams.
Accountable for product maintenance and compliance activities associated with marketed brands.
Partner with marketing companies (countries) 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 Strategy
Regulatory Affairs
Oncology
Multiple Myeloma
Health Authority Interactions
Stakeholder Management
Team Leadership
Strategic Thinking
Critical Evaluation
Risk Assessment
Cross-functional Teamwork
Communication Skills
Organizational Skills
Adaptability
Project Management
Due Diligence
Business Alliance
Coaching
Mentorship

Location

Remote
Hybrid

Work Type

Full-time
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
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

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines for serious diseases.
The company is dedicated to being a Great Place to Work, empowering employees to push scientific boundaries, challenge convention, and unleash entrepreneurial spirit.
AstraZeneca embraces differences and takes bold actions to address global healthcare and sustainability challenges, offering a place to make a difference in medicine, patients, and society.
The company fosters an inclusive culture where diverse thinking generates new opportunities, with a commitment to lifelong learning, growth, and development.
The Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using diversity to push scientific boundaries and deliver life-changing medicines.
Innovation at AstraZeneca relies on breakthrough ideas from a diverse workforce empowered to challenge conventional thinking.
The company values curiosity, creativity in approaching challenges, accountability, and a people-centric approach.
AstraZeneca promises to help colleagues realize their full potential, enabling them to do work that can change lives and improve countless others, while shaping a culture that unites and inspires.

Equal Opportunity

AstraZeneca is committed to building an inclusive environment where equal employment opportunities are available to all applicants and employees.
The company welcomes and considers applications from all qualified candidates, regardless of protected characteristics.
If you have a disability or special need requiring accommodation, please complete the corresponding section in the application form.