Gaithersburg, Maryland, United States · Hybrid
$186k–$279k/yr
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Introduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients? In this Director ro…
Skills: Global Regulatory Strategy, Cell Therapy, Health Authority Engagement, BLA Development, Cross-functional Leadership
Gaithersburg, Maryland, United States · On-site
Introduction to Role Here at AstraZeneca, you'll have the opportunity to make a difference in people's lives every day. As a Senior Scientist in the Virology Research Team within the Early Infectious Disease (eID) unit i…
Skills: Virology, Cell-Based Assay Development, Viral Propagation, Neutralization Assays, Laboratory Automation
Gaithersburg, Maryland, United States · On-site
$18/hr–$20/hr
Benefits: 401(k) Health insurance Paid time off Benefits/Perks Flexible Scheduling Competitive Compensation Careers Advancement Job Summary We are seeking a Certified Nursing Assistant (CNA) to join our team. In this pos…
Skills: Patient Care, Vital Signs Monitoring, Personal Hygiene Assistance, Mobility Assistance, Physical Therapy Exercises
Gaithersburg, Maryland, United States · On-site
$22/hr–$25/hr
Position Summary / Scope of Responsibility The Centers for Advanced Orthopaedics LLC (CAO) is one of the nation’s largest Orthopaedics practices, owned and operated by physicians, with over 60 locations across Mary…
Skills: Customer Service, Medical Terminology, Microsoft Office, Patient Scheduling, Insurance Verification
Gaithersburg, Maryland, United States · On-site
$151k–$227k/yr
Why AstraZeneca: AstraZeneca is a global, science-led, patient-focused pharmaceutical company. We are leading a revolution in oncology to redefine cancer care. Our bold ambition is to eliminate cancer as a cause of death…
Skills: Digital Marketing, Non Personal Promotion, Project Management, Budget Management, Cross-functional Collaboration
Gaithersburg, Maryland, United States · On-site
$184k–$276k/yr
At AstraZeneca, we are proud of our ground-breaking pipeline and continue to look for new ways to bring the best medicines to patients. We are building and fostering high-performing collaborative teams across the organiz…
Skills: Biobanking, Facilities Management, Lab Operations, Project Management, Regulatory Compliance
Gaithersburg, Maryland, United States · On-site
$148k–$174k/yr
Your Role: At Miltenyi Biotec, our North America Finance team plays a critical role in supporting our patient-focused biotech organization dedicated to helping make cancer history. We are not only pioneers in science&mda…
Skills: IFRS, Financial Reporting, Internal Controls, Inventory Accounting, Manufacturing Accounting
Gaithersburg, Maryland, United States · On-site
$92k/yr
Job Title: Manager, Clinical Pathology Qualifications: At least 10 years medical laboratory experience. MT certification is required. Knowledge of Good Laboratory Practices (GLP) and regulatory agencies is desirable. Cor…
Skills: Laboratory Operations, Personnel Management, Quality Control, GLP Compliance, SOP Development
Wilmington, Delaware, United States · On-site
$96k–$144k/yr
About the job Would you like to use your expertise to transform trade compliance a company that follows the science and turns ideas into life-changing medicines? If so, join our team as a Manager – US Customs Operations …
Skills: Customs Operations, Trade Compliance, FTZ Management, Import/Export Operations, Regulatory Compliance
Gaithersburg, Maryland, United States · On-site
$55/hr–$62/hr
Make an Impact as a Registered Nurse at BAYADA Home Health Care BAYADA Home Health Care is currently seeking a Registered Nurse (RN) to join our Montgomery Maryland Visits office for a full time opportunity. You will be …
Skills: Head-to-toe Assessment, Acute Care, Post-acute Care, Wound Care, Iv Therapy
Gaithersburg, Maryland, United States · On-site
BAYADA Home Health Care is currently seeking an experienced Speech Language Pathologist, SLP, for a per diem opportunity performing home health visits for our office located in Gaithersburg, MD. This office services adul…
Skills: Speech Therapy, Patient Evaluation, Treatment Planning, Patient Education, Electronic Medical Records
Gaithersburg, Maryland, United States · Remote OK
$55k–$105k/yr
About Blackbird Health Blackbird Health is clinician-founded, owned, and operated by dedicated professionals. We believe that providing the best care for children starts with building the best possible team. We deliver v…
Skills: Clinical Assessment, Psychotherapy, Telehealth, Evidence-Based Practice, Case Management
Gaithersburg, Maryland, United States · Hybrid
$148k–$190k/yr
WHY JOIN US? At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new…
Skills: Strategic Communications, Culture Change, Change Management, Stakeholder Engagement, Narrative Crafting
Gaithersburg, Maryland, United States · Hybrid
$288k–$432k/yr
Location: Gaithersburg, MD Hybrid: 3 days a week onsite The Senior Medical Director will be focused on Kidney Disease and related conditions that impact kidney function. In this role, you will have the opportunity to wor…
Skills: Clinical Trial Design, Data Interpretation, Regulatory Compliance, Biomarkers, Surrogate Endpoints
Gaithersburg, Maryland, United States · Hybrid
$136k–$204k/yr
Leverage technology to impact patients and ultimately save lives Do you have expertise in, and passion for information technology? Would you like to apply your expertise to impact the IT strategy in a company that follow…
Skills: Detection Engineering, Threat Modeling, SIEM, EDR, NDR
Gaithersburg, Maryland, United States · On-site
$19/hr–$20/hr
Company Description Today is a new day. At Asbury we’re filling it with more laughter, more possibilities, more ways to give back, all backed by support for whatever life brings your way. We are an organization with a mi…
Skills: Recipe Following, Food Production, Garnishing, Steam Table Setup, Temperature Monitoring
Gaithersburg, Maryland, United States · On-site
Residential Rehabilitation Program (RRP) services are designed for individuals with serious mental illness who have difficulty maintaining housing. Our team helps individuals obtain housing, employment, mental health ser…
Skills: Residential Counseling, Crisis Intervention, Medication Compliance, Case Management, Patient Advocacy
Gaithersburg, Maryland, United States · On-site
Residential Rehabilitation Program (RRP) services are designed for individuals with serious mental illness who have difficulty maintaining housing. Our team helps individuals obtain housing, employment, mental health ser…
Skills: Residential Counseling, Crisis Intervention, Medication Compliance, Case Management, Patient Advocacy
Gaithersburg, Maryland, United States · Hybrid
$161k–$241k/yr
Job Title: Americas Regional Network Technical Director Introduction to role: Are you ready to lead and innovate in the dynamic world of network services? As the Americas Regional Network Technical Director, you'll be at…
Skills: Network Strategy, SD-WAN, Wireless Networking, Network Security, Vendor Management
Gaithersburg, Maryland, United States · On-site
$56k–$81k/yr
Support Center If you are a current Adventist HealthCare employee, please click this link to apply through your Workday account. Adventist HealthCare seeks to hire an experienced Internal Auditor who will embrace our mis…
Skills: Internal Auditing, IIA Standards, Data Analysis, ACL Software, Regulatory Compliance
Gaithersburg, Maryland, United States • Hybrid
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Lead the global regulatory strategy for complex cell therapy products from development through submission and approval. Drive Health Authority interactions and collaborate cross-functionally to ensure competitive labeling and timely market access.
Requires an advanced science degree and 5-8 years of experience in regulatory affairs and biologic development. Proven expertise in leading cross-functional teams and managing interactions with major global Health Authorities is essential.
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy
Introduction to role:
Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care for patients?
In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.
You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from expedited designations and Health Authority interactions through major submissions and post-approval maintenance—helping the business deliver transformative therapies at pace and with rigor.
Can you see yourself guiding a complex program from pivotal data through approval and beyond while keeping patient value and global needs front and center?
Accountabilities:
Global Regulatory Strategy: Contribute to and implement the global regulatory strategy for a complex CGT product or indication from current stage through key submission milestones; support product maintenance activities as needed.
Program Leadership: Serve as regulatory lead for a product, indication, or defined program component; may serve in a dual role as Global Regulatory Lead and regional regulatory lead.
Approval Path and Labeling: Ensure regulatory strategies enable an efficient path to approval with competitive labeling aligned to product characteristics and business, market, and patient needs; contribute to governance presentations.
Health Authority Engagements: Drive strategy and execution for Health Authority meetings, responses to information requests, expedited pathway designations, and BLA development and submission.
Data-Driven Decision-Making: Maintain strong disease area knowledge; lead objective assessments of emerging data versus program aspirations; communicate risks and mitigation plans to senior management.
Milestone Delivery: Support delivery of all project-related regulatory milestones, including probability-of-success assessments and mitigation strategies.
Core Documents and Labeling: Lead preparation of regulatory strategy documents and target product labeling; support planning and assembly of the global dossier and core prescribing information with the respective teams.
Cross-Functional Collaboration: Operate as a core member of the Global Product Team and Global Regulatory Strategy Team, demonstrating strong strategic, communication, and collaboration skills to advance development objectives.
Process Excellence: Participate in non-project initiatives to enhance regulatory processes, tools, and practices; foster knowledge sharing across locations and therapy areas.
Country and Regional Alignment: Partner with country organizations and regional regulatory colleagues to align on evolving views, local considerations, and regulatory guidance.
Team Development: Provide mentoring and matrix support to less experienced colleagues; may have limited line management responsibilities.
Essential Skills/Experience
Desirable Skills/Experience:
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.
Why AstraZeneca: Here, regulatory leaders help transform pioneering science into therapies that reach patients faster—by driving innovative approaches, smart risk-taking, and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition, bringing unexpected teams together to unlock knowledge and sharpen strategy.
Our globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard, your growth supported, and your impact visible in every milestone we achieve.
The annual base pay for this position ranges from $186,232 - $279,349 USD USD Annual. 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 salary (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.
Call to Action: Step into a role where your regulatory leadership accelerates life-changing therapies—seize this opportunity to shape strategy, deliver approvals, and grow your influence today.
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.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
There are currently 349 open healthcare positions in Gaithersburg, MD listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include AstraZeneca, Asbury Communities, Inc., Adventist HealthCare, Sheppard Pratt, MESO SCALE DIAGNOSTICS, LLC., among others. Browse the listings above to see every active employer.
Yes — 92 of the 349 open healthcare positions offer remote or hybrid work (6 remote, 86 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
