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AstraZeneca
AstraZeneca
H1B Visa SponsorBiotechnologyHealthcarePharmaceuticals
AstraZeneca is a science-led biopharmaceutical company developing and commercializing prescription medicines for major health challenges. Its work covers oncology, cardiovascular, renal and metabolic conditions, and respiratory disease, combining pharmaceutical research with development and global delivery. With operations across more than 100 countries, AstraZeneca brings together teams focused on advancing treatments and improving outcomes for patients worldwide.
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Director, Regulatory Affairs Strategy – Cell Therapy | AstraZeneca (Hybrid, Gaithersburg)

Lead global regulatory strategy for AstraZeneca’s cell therapy programs, guiding health-authority engagement, submissions, labeling, and cross-functional development plans.

USUnited StatesCACaliforniaMDMaryland
$186,232 – $279,349 / year
HybridFull-timeLeadEnglish RequiredTherapist
Assembly

Description

  • Shape and execute global regulatory strategies for complex cell therapy products or indications through major submission milestones
  • Support ongoing product maintenance activities
  • Act as regulatory lead for a product, indication, or defined program component
  • Design efficient approval pathways and competitive labeling that reflect product, business, market, and patient needs
  • Lead health-authority meetings, responses to information requests, expedited pathway designations, and BLA preparation and submission
  • Evaluate emerging data against program objectives and communicate risks and mitigation plans to senior management
  • Support regulatory milestones, probability-of-success evaluations, and related mitigation planning
  • Own regulatory strategy documents and target product labeling
  • Help plan and compile global dossiers and core prescribing information
  • Contribute to Global Product and Global Regulatory Strategy teams
  • Improve regulatory processes, tools, and practices while promoting knowledge sharing
  • Collaborate with country organizations and regional regulatory colleagues
  • Mentor less experienced colleagues and provide matrix support, with limited line-management responsibilities possible

Requirements

  • Bachelor’s degree in a science-related discipline
  • At least five years of regulatory experience, preferably in cell therapy
  • Knowledge of global regulatory science and its integration with program strategy
  • Extensive experience across drug and biologic development processes and strategies for high-profile, complex, or novel programs
  • Broad pharmaceutical business experience and regulatory affairs experience spanning multiple areas
  • Demonstrated leadership of regulatory and cross-functional teams, including stakeholder management
  • Strategic and critical thinking skills with the ability to assess regulatory risks
  • Experience leading health-authority interactions in major markets
  • Strong oral, written, and presentation abilities
  • Highly organized approach to work
  • Ability to work hands-on in a fast-paced environment
  • Flexible, proactive approach with the ability to manage multiple projects and changing business priorities

Benefits

  • Opportunity to earn a short-term incentive bonus
  • Eligibility for an equity-based long-term incentive program in salaried roles
  • Access to a qualified 401(k) retirement plan
  • Paid vacation and holidays
  • Paid leave programs
  • Medical, prescription drug, dental, and vision coverage
  • Flexible working arrangement with an average minimum of three office days per week

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