LogoFresh Jobs Ahead
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.
LinkedIn
Company Jobs

Senior Director of Regulatory Affairs Strategy, Cell Therapy

Lead global regulatory strategy for AstraZeneca’s cell therapy programs from development through approval. Drive health authority engagement, BLA submissions, labeling, and cross-functional leadership.

USUnited StatesCACaliforniaMDMarylandMAMassachusetts
$218,058 – $327,087 / year
HybridFull-timeSeniorEnglish RequiredTherapist

Description

  • Define the global regulatory vision for cell therapy programs
  • Lead major programs in cancer, immune-mediated, and rare diseases through licensure
  • Own global regulatory strategy for complex cell therapy programs through BLA submission
  • Act as global regulatory lead for complex, multi-indication programs and, where applicable, regional lead
  • Direct health authority meeting strategies, information requests, and expedited pathway designations
  • Oversee global dossier and core prescribing information planning and development
  • Set target product labeling strategy and prepare for negotiations
  • Represent Regulatory Affairs on Global Product Teams and influence development and commercialization plans
  • Coordinate regulatory objectives with clinical, CMC, safety, and commercial strategies
  • Evaluate emerging data and communicate risks, trade-offs, and mitigations to senior leadership
  • Manage regulatory deliverables, milestones, probability-of-success assessments, and contingency plans
  • Lead, coach, mentor, and potentially manage members of the Global Regulatory Strategy Team
  • Develop relationships with regulatory stakeholders and collaborate with country and regional regulatory teams
  • Guide the development of innovative regulatory tools and technology
  • Support non-project initiatives that increase organizational impact
  • Maintain accountability for marketed product maintenance and compliance activities

Requirements

  • Bachelor’s degree in a science-related discipline
  • At least seven years of regulatory affairs experience
  • Successful track record developing regulatory strategy for cell therapies
  • Deep knowledge of global regulatory science and its integration with program strategy
  • Extensive experience across drug and biologic development processes, including high-profile, complex, or novel programs
  • Product development experience in oncology, autoimmune disease, rare diseases, and neurology
  • Broad pharmaceutical business experience and previous work across multiple regulatory affairs functions
  • Demonstrated ability to lead regulatory and cross-functional teams and manage stakeholders
  • Strategic and critical thinking skills with the ability to assess regulatory risks
  • Experience leading Health Authority interactions in major markets
  • Excellent verbal, written, and presentation skills
  • Strong organizational and planning abilities
  • Ability to work hands-on in a fast-paced environment
  • Flexible, proactive approach with the ability to manage multiple projects and changing priorities
  • Successfully led at least one global regulatory approval, including response-team leadership and labeling negotiations
  • Experience with an FDA advisory committee and/or EMA oral explanation
  • Experience supporting due diligence and working in a business alliance environment
  • Experience developing people through coaching or mentorship
  • Experience contributing to non-project business initiatives

Benefits

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

Related Jobs

Joma Jewellery & Katie Loxton

Customer Experience Specialist (Fixed-Term Contract) – Joma Jewellery & Katie Loxton

Joma Jewellery & Katie Loxton
51 – 200 Employees
FashionRetail
GBUnited Kingdom
£26,436 / year
HybridContractMiddleSeniorEnglish RequiredCustomer Support
Magento

Support Joma Jewellery and Katie Loxton customers by phone, email and webchat, processing refunds and resolving service issues. Coordinate with ecommerce and operations teams in a predominantly remote role with monthly visits to the Banbury office.

Open