Director, Patient Experience & Regulatory Engagement

Regulatory Toolkit; Boston (MA); On-site; USD 152,000 - 228,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation and holidays

Equity-based long-term incentive

Job summary

Regulatory Jobs is seeking a senior leader to integrate patient experience data into regulatory submissions. You will bridge Global Medical Affairs, R&D, Marketing, Market Access, and patient communities to shape evidence used in regulatory interactions.

The role drives PED generation, combining patient preference, lived experience, and patient-reported outcomes to support decision-making and access. Travel 20-30% may be required.

Qualifications

• Bachelor’s degree in data science or management preferred.
• 10+ years of experience in Biotech/Pharmaceutical industry or equivalent; preference for Regulatory/Clinical Development/Consulting.
• Experience developing innovative solutions and adapting quickly to disease areas and team needs.
• Ability to influence senior leaders and drive strategic decisions in global matrix organizations.
• Willingness to leverage AI and emerging technologies to enhance efficiency and decision-making.

Responsibilities

• Leads cross-functional strategy with Development and Regulatory teams to integrate patient experience data into regulatory submissions.
• Translates shifts and trends in regulatory landscape to inform PED generation and implementation, including HTA and payor expectations.
• Provides strategic leadership across teams and patient community stakeholders to generate PEDs (patient preference, patient-generated, lived-experience) informing risk/benefit narratives.
• Leads strategic vendor partnerships with clearly defined scopes and timely high-quality outputs.
• Limited domestic and international travel (20-30%).

Skills

Data science

Regulatory strategy

Stakeholder management

Patient experience data

AI/emerging tech

Education

Bachelor’s degree in data science or management

Job description

This is what you will do:

The Patient Experience Team (PEX)fuels AlexionAstraZeneca Rare Disease’scorporate priorities by ensuring the patient voice guides every stage of our work.Increasinglyglobal regulators,and decision makers such asHTA bodies and payorsrecognizethevalueoflivedpatient experience data (PED) to informtherapeuticdevelopment regulatory decision-makingin line withguidanceincluding patient-focused drug development,while supporting coverage and access decisions that canimprovereal-world outcomes.

ThePatientExperienceandRegulatory Engagement roleserves as a strategic bridge betweenGlobal Medical Affairs, R&D,Global Marketing& MarketAccessand the patient community. The roleleadsthe synthesis and application of PED,including patient preference studies,lived experiencedataand, patient reportedoutcome measuresto ensure the patient perspective isintegratedacross the medical product lifecycle.The role provides strategic leadership for theincorporation of patient perspectives into regulatory interactions, including preparatorystrategyfor patient participation in key meetings whereappropriate.

You will be responsible for:

• Leads cross functionalstrategywith Development and Regulatory teams to advance the integration of patient experience data into regulatory submissions.
• Translatingshifts and trends in the regulatory landscape that will informpatientexperience datageneration strategiesand proper implementationincluding access expectations for HTAsand payor bodies
• Provides strategic leadershipacrosscross-functional teams and patient community stakeholders to generate patient experience data (PED)—including patient preference, patient-generated, and lived-experience evidenceultimately shapingpatient‑informed risk/benefit narratives to support external stakeholder interactions.
• Lead strategic vendor partnerships on targeted initiatives, ensuring clear scope definition, effective stakeholder management, andtimelydelivery ofhighqualityoutputs.
• Limited domestic and international travel (20-30%) with the ability to travel to meet with key stakeholders.

You will need to have:

• Bachelor’sdegree:degree in data science or managementpreferred.
• 10+ years of experience in the Biotech/Pharmaceutical Industry or equivalent; preference for experience inRegulatory, ClinicalDevelopment, or Consulting.
• Experience developing innovative solutionsand abilitytoadapt quicklyto disease‑area and team needs.
• Drive changeby transformingtraditional data‑use practices into leading‑edge, modern approachesworking in partnership with colleagues.
• Demonstrated passion for patient and caregiver focusedwork.
• Demonstrated ability to influence senior leaders and drive strategic decisions across complex global matrix organizations
• An understanding of patient-focused drug development, experience generating or synthesizing patient experience data as part of regulatory submissions
• Demonstrated willingness and ability toleverageartificial intelligence and other emerging technologies to enhance efficiency, insight generation, and decision-making.
• Demonstrated ability to lead complex global initiatives, influence diverse stakeholder groups, and drive execution through matrix teams.
• The duties of this role aregenerally conductedin an office environment.As is typical of an office-based role, employees must be able, with or withoutan accommodationto:use a computer; engage incommunicationsvia phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Advanced degreea plus(e.g.,MPH, MBA,MPA,PhD.MDetc.)
• Experience orpreviousengagementworking for orwith regulatory authoritiesand/or payor bodies
• Experience in Rare Disease
• Knowledge ofregulatory authoritiesin multiple countries
• Proficiencyin one or more languages in addition to English

The annual base pay for this position ranges from $151,600- $227 -700. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

02-Nov-2026

Closing Date

29-Nov-2026

Our 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.