A

AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior Director, Regulatory Affairs - Oncology Cell & Gene Therapy

Full-TimeDeadline 10/28/26
$218.1k - $327.1k/yr+ Short-term incentive bonus + Equity-based long-term incentive program
Senior, Expert
Bachelor's
South San Francisco, CA, USA+1 moreMore locations: Gaithersburg, MD, USA
HybridThree days per week in the office.
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • An advanced degree in a science-related field and seven to ten years of experience and/or appropriate knowledge and experience.
  • Demonstrated success in cell and/or gene therapy regulatory strategy.
  • Deep understanding of global regulatory science and its integration with program strategy.
  • Long-standing experience with overall drug and biologic development processes and strategies for high-profile, complex, or novel development programs.
  • Experience with product development for multiple myeloma.
  • Broad experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
  • Proven experience leading regulatory and cross-functional teams and managing stakeholders.
  • Ability to think strategically and critically and evaluate risks to regulatory activities.
  • Previous experience leading major Health Authority interactions.
  • Strong organizational skills.
  • Ability to work hands-on in a fast-paced environment.
  • Ability to manage multiple projects and adapt to changing business needs and priorities.
Responsibilities
  • Lead and own development and implementation of the global regulatory strategy for a high-complexity cell and gene therapy product, from its current stage through BLA submission; may serve in a dual role as Global Regulatory Lead and regional Regulatory Affairs Director.
  • As a core member of the global product team, ensure regulatory strategies support an efficient path to approval with competitive labeling aligned with product properties and the needs identified by the business, markets, and patients, and contribute to governance presentations.
  • Lead regulatory strategy for health authority meetings, responses to information requests, BLA development and submission, and expedited pathway designations.
  • Maintain strong working knowledge of relevant disease areas, including early- and late-stage multiple myeloma.
  • Lead a Global Regulatory Strategy Team for specific indications or programs within the franchise, including regional contributors, emerging markets, Regulatory Affairs Chemistry, Manufacturing and Controls, Labeling, and submission and execution team members; participate in coaching and performance feedback for team members.
  • Lead objective assessment of emerging data against aspirations and update senior management on project risks and mitigation activities.
  • Represent Regulatory Affairs on Global Product Teams, provide strategic regulatory advice, and be accountable for regulatory activities.
  • Be accountable for delivery of 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.
  • Contribute strategic leadership and collaboration to effective cross-functional teamwork in product development.
  • Lead, participate in, and promote non-project functional or cross-functional initiatives, engaging externally on corresponding topics as needed; lead development of novel regulatory tools and technology.
  • Ensure appropriate planning and construction of the global dossier and core prescribing information by the respective teams; be accountable for product maintenance and compliance activities associated with marketed brands.
  • Partner with marketing companies and regional regulatory affairs staff to influence developing views and guidance.
  • May have line management responsibilities in addition to matrixed supervisory, leadership, and mentoring roles.
Desired Qualifications
  • Experience in oncology involving small molecules and biologics.
  • Successful leadership of at least one global regulatory approval, including leading the response team and labeling negotiations.
  • Experience with FDA advisory committee and EMA oral explanation.
  • Experience developing products for treatment of autoimmune conditions.
  • Experience with due diligence activities and in a business alliance environment.
  • Experience leading and growing people through coaching or mentorship.
  • Contribution to non-project business initiatives, such as portfolio-level or cross-functional initiatives.

About the company

AstraZeneca develops and markets prescription medicines and vaccines for global health, focusing on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells to treat diseases or prevent infections, using small-molecule drugs, biologics, and vaccines. The company differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D with collaborations to move from discovery to patient access across multiple therapeutic areas. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines worldwide.

Company Size

10,001+

Company Stage

IPO

Headquarters

Cambridge, United Kingdom

Founded

1913

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Simplify Jobs

Simplify's Take

What believers are saying

  • Massachusetts expansion adds nearly 2,000 scientists and expands workforce over 50% by 2026.
  • H1 2026 revenue rose 6% to $30.7 billion, driven by oncology growth.
  • FLAURA2 and CLARITY-Gastric01 strengthened Tagrisso and sonesitatug vedotin in 2026.

What critics are saying

  • Farxiga faced US and Japan generic competition, plus China VBP, in H1 2026.
  • Forxiga patent fights continue in France, Poland, Portugal, and Australia through 2027.
  • Tagrisso dependence stays acute; one patent loss or trial failure would crush growth.

What makes AstraZeneca unique

  • Pascal Soriot doubled down on oncology, opening Cambridge R&D center October 5, 2026.
  • AstraZeneca's ADC and bispecific platform drove the $2 billion Summit Therapeutics deal September 28, 2026.
  • Tagrisso, Imfinzi, and rare disease franchises keep AstraZeneca diversified across high-value therapeutic categories.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Vacation

Paid Holidays

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

6%

1 year growth

6%

2 year growth

6%
Yahoo Finance
Oct 10th, 2026
AstraZeneca launches AI-driven biologics discovery with Carterra to accelerate drug development

AstraZeneca has launched an AI-driven biologics discovery collaboration with Carterra, announced ahead of trading on 9 October 2026. The partnership links AstraZeneca's AI models with Carterra's high-throughput biosensor instruments to create autonomous, lab-in-the-loop discovery workflows. The project focuses on large molecule biologics, aiming to shorten experimental decision cycles and scale up antibody and protein engineering campaigns. AstraZeneca operates at a £186.1 billion market capitalisation. The collaboration addresses AstraZeneca's strategy of using AI to accelerate drug development cycles and support higher net margins through more efficient research and development. The partnership enables tighter lab-in-the-loop cycles where AstraZeneca's biologics engine can be iterated by machines rather than manual trial and error.

Zyme Communications
Oct 7th, 2026
Carterra advances lab-in-the-loop drug discovery through new scientific collaboration.

Carterra advances lab-in-the-loop drug discovery through new scientific collaboration. Bringing together scientific and technical expertise to advance development of hardware and software aimed at enabling a new wave of AI-driven, autonomous biologics discovery Salt Lake City, Utah, 07 October, 2026: Carterra(R), a leading provider of high-throughput surface plasmon resonance (HT-SPR(TM) platforms for antibody and small molecule drug discovery, today announced a research collaboration with AstraZeneca to develop hardware and software aimed at advancing lab-in-the loop drug discovery. The effort brings together scientific and technical expertise to connect laboratory systems, software and data infrastructure with AI-driven discovery workflows. Lab-in-the-loop - the model in which AI systems propose drug candidates, wet-lab experiments generate data to test those predictions, and the resulting data feeds back to refine the next round of AI-guided design - is a growing area of interest to the pharmaceutical industry. A July 2026 Leerink Partners report described lab-in-the-loop as an emerging paradigm reshaping antibody discovery. A similar William Blair analysis pointed to the same shift as a driver of increased wet-lab data generation industry-wide. Many of the largest biopharma have described efforts to link AI models directly to autonomous laboratory experimentation and to connect computational drug design with experimental validation at scale. AstraZeneca is among the pharmaceutical companies pursuing these approaches. Central to this model is the availability of experimental data that is consistent and comparable across large numbers of experiments - something the scientific and AI communities have identified as one of the central barriers to applying AI meaningfully in structural and biophysical drug discovery. To advance both hardware and software needed to close the loop, Carterra's engineering and software teams are working together with AstraZeneca's scientists and automation experts, to create laboratory systems capable of generating standardized data at scale with software designed to make that data directly usable in AI and machine learning workflows. "Working with one of the world's leading biopharmaceutical companies to help shape the next chapter of drug discovery is exactly the kind of collaboration our industry needs," said Josh Eckman, CEO of Carterra. "AstraZeneca brings deep experience running biologics discovery at scale, and the willingness to commit real scientific and automation resources reflects how urgently the field is moving toward a truly connected, AI-enabled discovery loop."

Life Science Connect
Oct 7th, 2026
Carterra advances lab-in-the-loop drug discovery through new scientific collaboration.

Carterra advances lab-in-the-loop drug discovery through new scientific collaboration. Salt Lake City, UT (BUSINESS WIRE) - Carterra(R), a leading provider of high-throughput surface plasmon resonance (HT-SPR(TM) platforms for antibody and small molecule drug discovery, today announced a research collaboration with AstraZeneca to develop hardware and software aimed at advancing lab-in-the loop drug discovery. The effort brings together scientific and technical expertise to connect laboratory systems, software and data infrastructure with AI-driven discovery workflows. Lab-in-the-loop - the model in which AI systems propose drug candidates, wet-lab experiments generate data to test those predictions, and the resulting data feeds back to refine the next round of AI-guided design - is a growing area of interest to the pharmaceutical industry. A July 2026 Leerink Partners report described lab-in-the-loop as an emerging paradigm reshaping antibody discovery. A similar William Blair analysis pointed to the same shift as a driver of increased wet-lab data generation industry-wide. Many of the largest biopharma have described efforts to link AI models directly to autonomous laboratory experimentation and to connect computational drug design with experimental validation at scale. AstraZeneca is among the pharmaceutical companies pursuing these approaches. Central to this model is the availability of experimental data that is consistent and comparable across large numbers of experiments - something the scientific and AI communities have identified as one of the central barriers to applying AI meaningfully in structural and biophysical drug discovery. To advance both hardware and software needed to close the loop, Carterra's engineering and software teams are working together with AstraZeneca's scientists and automation experts, to create laboratory systems capable of generating standardized data at scale with software designed to make that data directly usable in AI and machine learning workflows. "Working with one of the world's leading biopharmaceutical companies to help shape the next chapter of drug discovery is exactly the kind of collaboration our industry needs," said Josh Eckman, CEO of Carterra. "AstraZeneca brings deep experience running biologics discovery at scale, and the willingness to commit real scientific and automation resources reflects how urgently the field is moving toward a truly connected, AI-enabled discovery loop." About Carterra Carterra is a leading provider of innovative technologies designed to accelerate the discovery of novel therapeutic candidates. Carterra's high-throughput LSA(R), LSA-XT, Carterra Ultra(R), and Carterra Vega(TM) platforms for monoclonal antibody and small molecule screening and characterization combine patented microfluidics with real-time high-throughput surface plasmon resonance (HT-SPR(TM) technology, integrated with industry-leading analysis software. (C) 2026 Business Wire, Inc. Like what you are reading?

Brand Innovators
Oct 6th, 2026
Innovator interviews: AstraZeneca's Rob Cori.

Innovator interviews: AstraZeneca's Rob Cori. By Mercedes Cardona October 6, 2026 The main health concern when consumers order Chinese food is usually whether the restaurant cooks with MSG. But AstraZeneca is hoping they will be open to a message of prevention during this flu season. In September, the pharmaceutical company kicked off an effort for its FluMist vaccine using fortune cookies as the medium. AstraZeneca partnered with OpenFortune, an agency that specializes in delivering messages printed in the fortune slips. Diners in restaurants and ordering deliveries via DoorDash and UberEats in California and New York began to receive cookies with messages promoting the nasal spray vaccine for at-home use. The slips included a QR code directing them to the brand's website for more information and to order doses. The fortune cookies have been dispersed and AstraZeneca will track results through December to decide whether to expand the pilot. "We've been hyper-focused on: How do we get more families to be aware? How do we get more consumers in general to be aware that they don't have to have a flu shot?" says Rob Cori, AstraZeneca's director of customer engagement capabilities. "We were exploring: well, how do we want to leverage either an existing capability or a new capability to really drive that awareness?" Cori's team is tasked with finding innovations in customer engagement, either new and emerging channels, so when he was introduced to Open Fortune by Brand Innovators, Cori was interested. FluMist was chosen for the pilot because the brand was willing to partner with the innovation team and try something different. Cori noted he and other team members come from outside the pharmaceutical world, so they are willing to test tactics outside the traditional pharma ads. Brand Innovators spoke to Cori about this unusual effort and how it fits into AstraZeneca's strategy. This interview has been edited for length and clarity. What's going on with consumers in the pharmaceutical space that leads you to try these new strategies? What its team is trying to do is pull experiences that consumers are used to outside of pharma in their everyday life and try to make them make sense for its world in pharma. Anyone that's had Asian cuisine has engaged with a fortune cookie. You may not eat it, but you're always going to go through the process of cracking and reading your fortune and seeing what it has to say. In this case, Brand Innovators felt: well, what better way to provide some sort of experiential moment for an individual where they're at a time of low stress, they're having an engaging meal, their guards are down, and they have the ability to process something that's being put in front of them? Brand Innovators felt like it was a great way to test: Does messaging hit in this type of environment where you're laid back in a more personal social setting, like eating a meal? I think what Brand Innovators is trying to do is take the best experiential types of marketing that are happening outside of pharma and using them in its world of pharma. But experiential marketing is tricky for pharmaceuticals due to regulations. Brand Innovators is being overserved a ton of pharmaceutical content on a daily basis in all different mediums, and there is this sense of both clinicians and patients/consumers getting to a place where they're pushing back and saying, "I'm tired of interacting, I'm tired of seeing this type of content." I think Brand Innovators ourselves as pharmaceutical customer engagers and marketers need to realize that Brand Innovators need to dial back in some ways, but also serve up new opportunities for them to engage in moments that matter in their life and not forcing it down their throats. In this case, it's a fun reaction to crack open a cookie and view something, versus spamming their social media and their phone 24/7 with messaging. Was this idea a hard sell within your organization? It was a fun sell, a challenging sell because Brand Innovators typically don't do things like this in the world of pharma. Brand Innovators has very traditional media spends -on TV advertising, banner advertisements digitally. But putting something inside of a fortune cookie and dispersing that in zip codes where Brand Innovators feel like its product has the best chance to win, that was kind of unheard of. A very new capability for Brand Innovators at AstraZeneca. But you've done some off-beat advertising for a pharma company, like the AI-generated llamas for the Breztri inhaler. Is that part of your strategy? The way that I think about my team's capabilities and innovation in general is it has to serve a purpose. I sort of split it up into two buckets. I focus on foundational innovation, and those are things that create better efficiencies within the business. They're not always the sexy, new, shiny toys or capabilities, but they're important things that you need to establish to better run the business. The disruptive innovation or the positive disruptive innovations, are finding new and emerging capabilities - that outside-of-the-box thinking that may sometimes fail, but it may sometimes win. That's where I'd categorize this capability. Brand Innovators is testing to learn it, but Brand Innovators has plans, wanting to scale and expand to other therapeutic areas as well, or a variation of it in some different capacity, once Brand Innovators learn about what the results are showing Brand Innovators. How do you measure results? Are they looking only for awareness or also behavior? Obviously awareness is extremely important. Ultimately, Brand Innovators want to get consumers and patients on the correct therapy for them or leveraging, in this case, the correct vaccine to protect themselves. So, one: Brand Innovators want to know that consumers are engaging with the content that they're viewing. Brand Innovators is looking to see if they're actually scanning the QR code and digesting the information, visiting its site, engaging with its site. And then, hopefully, if Brand Innovators is doing its job correctly, Brand Innovators is getting individuals on the proper vaccine for the flu, which is FluMist. Those are all things that Brand Innovators'll ultimately look for as the pilot completes. So you might try this with other products? It depends on the therapeutic area. It depends on the product. It has to make sense for the demographic that Brand Innovators is trying to get in front of versus the actual capabilities of OpenFortune. I will say, though, that I'm actively meeting with them and exploring some new capabilities that Brand Innovators may partner on, outside of the world of fortune cookies, that Brand Innovators may also scale to. I don't have any further details to share on those yet, but I will say that Brand Innovators is exploring all different types of potential outside-of-the-box capabilities to get its messaging in front of consumers.

Business Insider
Oct 6th, 2026
Robotics startup Multiply Labs raises $75M to automate drug manufacturing

Multiply Labs, a San Francisco robotics startup automating drug manufacturing, raised $75 million in Series B funding led by NantWorks. The round brings total funding to over $100 million since 2016. The company builds robots that manufacture complex drugs like gene therapies and mRNA treatments, which are typically made manually in laboratories. Production costs for some gene therapies exceed $1 million per dose, according to 2025 research. Multiply's robots currently cost several million dollars each to build. Drugmakers including AstraZeneca and Legend Biotech purchase and operate the machines at their facilities. Multiply also generates revenue from cartridges and service support. The company has deployed a high single-digit number of machines with customers. CEO Fred Parietti said robotics is essential to achieve necessary throughput, cost reduction, and quality in drug manufacturing.