Jobs in the United States

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Added 1 min ago
8L
Entry-Level Manager Trainee (relocation required after six months in Bakersfield)
84 Lumber Company
Bakersfield, CA
- $18 USD / hour
…(based on performance and position availability), which can lead to up to a 40% increase in annual pay. Many Manager Trainees progress to General Manager roles within 3-4 years. Manager…
Added 2 mins ago
YN
Nuclear Med Tech (Part-Time | 24 Hrs | Benefits Eligible
Yale New Haven Health
NEW HAVEN, CT
- Part-time
Nuclear Med Tech (Part-Time | 24 Hrs/Wk | Benefits Eligible | Day Shift | Monday, Tuesday, & Friday) · Must have a basic knowledge of radiopharmaceuticals, nuclear medicine equipment and nuclear medicine imaging procedures
Added 5 mins ago
Sales Lead COM
Republic National Distributing Company
Atlanta, GA
If no Support rep partner, Sales lead is responsible for merchandising activities (e.g., stocking shelves, building displays, etc.)
Added 5 mins ago
Sales Lead COM
Republic National Distributing Company
Atlanta, GA
If no Support rep partner, Sales lead is responsible for merchandising activities (e.g., stocking shelves, building displays, etc.)
Added 5 mins ago
Sales Lead COM
Republic National Distributing Company
Atlanta, GA
If no Support rep partner, Sales lead is responsible for merchandising activities (e.g., stocking shelves, building displays, etc.)
Added 5 mins ago
People Compliance Specialist
Anduril Industries
Ashville, OH · Costa Mesa, CA
Support the maintenance and continuous improvement of People Team policies, procedures, forms, templates, and process documentation, including communication and acknowledgment tracking.
Added 6 mins ago
Founding Strategic Partnerships, Cloud & Alliances
George Bernard Consulting
San Carlos · San Carlos, CA
Lead partner-sourced and joint-selling deals from first contact to close.
Added 7 mins ago
Program Manager 3- ESPASat Product Line (Active Top Secret required)
SP - Orbital Space Systems
United States
…all technical requirements and creating customer intimacy to support value creation strategies and actions. The individual will lead a cross-functional organization aligned to common…
Added 7 mins ago
Principal / Sr. Principal Electronics Engineer – Precision Sensor Electronics
CORP-Corporate Office
United States
…campus in the greater Los Angeles area, our engineering teams support programs across Navigation and Cockpit Systems (NACS) and Emerging Capabilities Development (ECD), spanning established…
Added 7 mins ago
Campus Executive Chef
Compass Group, North America
KENOSHA, WI
Bon Appétit is seeking a creative, people-focused Campus Executive Chef to lead the culinary vision and day-to-day kitchen operations at Carthage College. This role is responsible for…
Added 7 mins ago
Subcontracts Intern
Oshkosh Corporation
Oshkosh, WI
As a Subcontracts Intern, you have the opportunity to assist with multiple levels of procurement to support our Global Procurement and Supply Chain (GPSC) teams within the corporation.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Las Vegas, NV
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Eugene, OR
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Houston, TX
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Dallas, TX
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Phoenix, AZ
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 7 mins ago
ZS
Electrical Controls Engineering Manager - Industrial Automation
Zen Sherpa LLC
Minneapolis, MN
- $150,000 to $190,000 USD / year
A growing industrial manufacturer is seeking an experienced Electrical & Controls Engineering Manager to lead electrical, controls, automation, and instrumentation engineering.
Added 8 mins ago
Spotlight Multimedia Creator
Varsity Brands
ID
Travel: Travel is required during our event season (January–July), and team members must reside within reasonable proximity to a U.S
Added 9 mins ago
CM
Care Navigator
Centene Management Company LLC
Remote, United States
- $22.94 to $38.79 USD / hour
…of Missouri. This team supports children with elevated blood lead levels and assists with transition of care outreach. The work schedule is Monday - Friday, 8am - 5pm. A Missouri LPN…
Added 12 mins ago
Middle/High School Math Teacher
Scottsdale Preparatory Academy
Scottsdale, AZ
…education coursework/pathways, to reduced tuition graduate degree support with select partner…
Added 14 mins ago
SN
Staff Software Engineer
Second Nature
Remote, United States
- $175,000 to $195,000 USD / year
Second Nature is looking for a highly experienced Staff Software Engineer to help lead the technical development of our GRI Internet product.
Added 15 mins ago
Community Affairs Manager
Nscale
United States
We are hiring a Community Affairs Manager for the greater Dallas–Fort Worth area to support the successful development and long-term operation of Nscale’s infrastructure locally.
Added 17 mins ago
PARK RANGER
Arizona Department of Administration
AZ
…natural areas. The agency also includes the statewide trails program, outdoor-related grants program, the State Historic Preservation Office, as well as the Off-Highway Vehicle Program, and…
Added 19 mins ago
Momentum ERP Acquisitions Expert
CGI Technologies and Solutions, Inc.
Fairfax, VA
…Agency? CGI Federal is seeking an experienced leader to join the program. Contribute to the continued growth of the program by bringing your expertise in support of program delivery, member…
Added 19 mins ago
MANAGEMENT AND PROGRAM ANALYST (CSOD)
Organization of the Joint Chiefs of Staff
Pentagon, VA

AstraZeneca

Regulatory CMC Director (Cell & Gene Therapy)

Gaithersburg, MD, United States
Gaithersburg, United States

$186,232 to $279,349 USD / year

Apply on astrazeneca.eightfold.ai About employer

Applications open in a new tab.

Job details

Pay: $186,232 to $279,349 USD / year
Apply by: May 5, 2027
Work location: This postion can be based in Santa Monica, CA or Gaithersburg, MD, or Boston, MA
Experience: Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD.
Posting language: English
Posted: Nov 6, 2026

Original job description

Are you ready to steer global CMC strategy for cell and gene therapies that redefine what’s possible for patients? This role positions you at the center of breakthrough programs, where your regulatory leadership translates pioneering science into high-quality submissions and decisive health authority interactions that accelerate access for people who need it most.

As a Director Regualtory Affairs CMC you will shape end-to-end CMC regulatory pathways across development stages, partnering closely with technical, clinical, and quality leaders. You will you apply your expertise to anticipate risk, set clear direction, and drive rapid, global approvals for a growing pipeline. This postion can be based in Santa Monica, CA or Gaithersburg, MD, or Boston, MA.

Accountabilities:

Global CMC Strategy: Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for cell and gene therapy programs, enabling efficient approvals and risk-mitigated plans.
Regulatory Intelligence and Risk Management: Interpret global regulations and guidance to identify risks and provide clear, actionable input to cross-functional product teams; deliver regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessments.
Dossier Leadership and Health Authority Engagement: Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports; develop health authority briefing documents; represent CMC regulatory affairs on product teams and in agency interactions; ensure submission quality, clarity, and accuracy.
Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle, ensuring timely updates and robust documentation strategies that support development, scale-up, and post-approval changes.
Standards and Ways of Working: Support the development and maintenance of regulatory templates, best practices, and procedures that raise quality, consistency, and speed of execution across programs.
People Leadership: Support hiring, lead workflow, and develop staff; build and guide high-functioning teams to deliver complex program milestones.
Continuous Improvement: Perform other duties as required, championing simplification and data-driven approaches that shorten development cycles and improve submission readiness.

Essential Skills/Experience:

Demonstrated ability to develop/maintain strong working relationships with cross-functional teams, participate on and/or lead multi-functional teams, handle and prioritize multiple projects, and work independently.
Excellent communication and collaboration skills to work in a fast paced start up environment.
Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
Ability to deal with time demands, incomplete information or unexpected events.
Attention to detail required.
Outstanding organizational skills with the ability to multi-task and prioritize.
MA/MS degree in life sciences required; advanced degree preferred (PhD, PharmD).
Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD.
Prior experience in cell/gene therapy.
In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
Experience in IND, IMPD, BLA, MAA filings.

Desirable Skills/Experience:

Direct experience leading health authority meetings and negotiating CMC strategies with multiple regions.
Expertise in CGT-specific comparability strategies, potency assays, and control strategy development.
Familiarity with eCTD publishing tools and document management systems.
Track record delivering expedited pathways or accelerated approvals.
Experience working across multiple sites and in highly matrixed, high-growth environments.
Comfort using analytics or automation to streamline regulatory processes and enhance submission quality.

Why AstraZeneca:

Join a place where regulatory innovators have the tools and trust to move fast and think boldly. Here, unexpected teams gather in the same room to unlock smarter pathways, using data and modern approaches to minimize barriers and shorten development cycles. You will be part of a globally connected community that shares best practice, values kindness alongside ambition, and turns transformative science into real value for patients. With a rich pipeline and the autonomy to be an agent of change, your impact will be tangible - from shaping strategy to seeing rapid, global approvals reach people who need them.

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $186,232 - 279,349. However, 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) or to receive a retirement contribution (hourly 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

Date Posted 06-Nov-2026 Closing Date 30-Nov-2026Our 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.

Apply on astrazeneca.eightfold.ai About employer

More about this job

Skills

Leadership
Risk management
Regulatory compliance
Regulatory affairs
Documentation
Workflow
Develop staff
Process improvement
Work independently
Communication skills
Collaboration
Attention to detail
Organizational skills
Document management

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Work requirements

Jobs in the United States