Regulatory Affairs Director

Regulatory Affairs Director

Oncology R&D

Gaithersburg, MD Hybrid Work- on average 3 days a week from office

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll serve as the global regulatory lead (GRL) on early-stage projects or be responsible for specific indications or jurisdictions of larger programs. You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions. The RAD also serves as the face of the company with Health Authorities.

What you'll do

• Accountable for leading the development and implementation of the regional or global regulatory strategy for a CGT product/group of products. Ensures that the strategy is designed for efficient development tailored to the global or specific regional regulatory environment(s), and to deliver approvals aligned to the needs of the business, markets and patients. This includes optimizing the health authority engagement strategy, aligning cross-functionally on messaging, planning the development of submission documents, and driving designation of applicable expedited regulatory programs such as FastTrack, RMAT, Breakthrough, and PRIME.
• Lead cross-functional teams in major regulatory submissions (NDA, IND/CTA), Health Authority interactions, label negotiations, and securing NDA/BLA approvals. This includes developing the strategy, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling, and members of the submission and execution team in formulating global regulatory strategy and delivering on NDA filings and approvals.
• As a regional regulatory lead, the RAD is accountable for providing the region-specific regulatory strategy and direction.
• May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities.
• Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling.
• Demonstrate strategic leadership skills contributing to product development. Provide team leadership in a matrixed environment and participate in coaching, and performance feedback to members of the GRST.
• Lead the objective assessment of emerging data and regulatory environments against aspirations and update senior management on project risks/mitigation activities.
• Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Essential for the role

• Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
• At least 5 years' experience in regulatory drug development or equivalent with a focus on cell and gene therapy products for malignant diseases.
• Experience with major Health Authority interactions including direct engagements with US FDA/CBER.
• Hands-on leadership of IND and pre-IND CGT programs.
• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
• Demonstrated competencies of strategic thinking, influencing, innovation, initiative, leadership and excellent oral and written communication skills.

Desirable for the role

• Scientific background in area relevant to oncology cell and gene therapy development.
• Understanding of non-clinical and CMC regulatory principles pertaining to CGT, including comparability and potency.
• A solid grasp of guiding principles in drug development. This includes benefit/risk profile, dose selection, and statistical development related to cell and gene therapy products. It also involves using small datasets to support Health Authority alignment.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Contribution to a regulatory approval including leading response team and labeling negotiations
• Ability to work strategically within a complex, business-critical and high-profile development program.
• Critical thinking on current global regulatory science and policy pertaining to CGT, and good understanding of the corresponding scientific and clinical components.
• Prior experience with phase 3 design including end of phase 2 health authority interactions

Office Working Requirements

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $178,534.40 - 267,801.60 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.