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 assignedcell and gene therapy(CGT)product(s).You'll serveasthe global regulatory lead (GRL)on early-stage projects orbe responsible forspecific indicationsorjurisdictionsoflarger programs. You'll have the opportunity to contribute significantly to product and clinical strategyand support cross-functional alignment for governance and health authority interactions. The RAD also servesas 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 aCGTproduct/group of products.Ensuresthat the strategy is designedfor efficient development tailored to theglobal or specificregional regulatory environment(s), andtodeliver approvalsaligned tothe needsofthe business,marketsand patients. This includesoptimizingthehealth authority engagement strategy,aligning cross-functionally on messaging, planning the development of submission documents,anddriving designation ofapplicableexpedited regulatory programssuch asFastTrack,RMAT, Breakthrough, and PRIME.
Lead cross-functionalteams inmajorregulatorysubmissions (NDA, IND/CTA), Health Authorityinteractions,labelnegotiations, and securingNDA/BLAapprovals.This includesdevelopingthe strategy, driving the formulation of the briefing document focused on strategy and scientific content, leading the team throughmeetingsrehearsals, 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 formulatingglobalregulatory strategy and delivering on NDAfilings andapprovals
As a regional regulatory lead, the RAD is accountable for providing the region-specificregulatory strategy anddirection.
May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs)providingstrategic 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.
Demonstratestrategic leadership skills contributing to product development.Provide team leadershipin a matrixed environmentandparticipatein coaching, and performance feedback to members oftheGRST.
Lead the objective assessment of emerging dataand regulatory environmentsagainst aspirations and update senior management on project risks/mitigation activities.
Ensureappropriate planningand 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 ascience relatedfield and/or otherappropriate knowledge/experience.
At least5 years’experienceinregulatory drug development or equivalentwith a focus on cell and gene therapy products for malignant diseases.
Experience with major Health Authority interactionsincluding 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.
Demonstratedcompetencies of strategic thinking, influencing, innovation, initiative,leadershipand excellent oral and written communication skills.
Desirable for the role
Scientific background inarearelevant tooncologycell and gene therapy development.
Understanding ofnon-clinical andCMC regulatory principlespertaining toCGT, 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-criticaland high-profile development program.
Critical thinking on current global regulatory scienceand policypertaining toCGT,andgoodunderstanding 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.
#LI-Hybrid
Date Posted
20-Apr-2026Closing Date
03-May-2026Our 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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
Rejoignez notre réseau de talents
Inscrivez-vous pour recevoir des alertes emplois AstraZeneca.
S'inscrire
