Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

AstraZeneca • South San Francisco, CA

3d • Hybrid

About The Position

The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location. The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Sr RAD provides team leadership and participates in coaching and mentorship to members of the relevant CGT Global Regulatory Strategy Team and is responsible for leading the global regulatory deliverables in line with GPT goals. The Sr RAD establishes external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage. They are viewed as a Senior Leader within the Regulatory Community.

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.
• 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.

Nice To Haves

• Experience in Oncology (small molecules & biologics) is preferred.
• 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)

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.

Benefits

• Competitive salary and benefits package on offer
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior