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Fda Cber Jobs (NOW HIRING)

Lexitas

Director, Regulatory Affairs (Fractional)

$153K - $202K/yr

CBER (Center for Biologics Evaluation and Research) * CDRH (Center for Devices and Radiological Health) Key qualifications include: * Extensive ophthalmology regulatory experience * Proven FDA ...

Ardelyx

Senior Director, Regulatory Affairs

Waltham, MA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

Ardelyx

Senior Director, Regulatory Affairs

Newark, CA · On-site

$259K - $317K/yr

Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C meetings, Scientific Advice, and Innovation Office engagements * Partner with ...

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How much do fda cber jobs pay per hour?

As of Aug 29, 2026, the average hourly pay for fda cber in the United States is $52.19, according to ZipRecruiter salary data. Most workers in this role earn between $45.19 and $63.46 per hour, depending on experience, location, and employer.

What is an FDA CBER?

An FDA CBER job refers to a position within the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). CBER regulates biological products, including vaccines, blood products, and gene therapies, to ensure their safety and effectiveness. Employees in CBER roles may work in regulatory affairs, scientific research, policy development, or compliance oversight. These positions typically require expertise in biology, medicine, or regulatory science.

What are the typical daily responsibilities of someone working at FDA CBER?

Professionals at FDA CBER are usually involved in reviewing scientific data, assessing regulatory submissions for biologics, writing evaluation reports, and participating in team meetings to discuss product review findings. They commonly collaborate with scientists, physicians, and policy experts to ensure biologic products meet safety and efficacy standards. Day-to-day tasks may also include responding to inquiries from industry sponsors, developing policy guidance, and staying abreast of advances in biologic product development. This dynamic environment allows for constant learning and impact on public health through regulatory science.

What are the key skills and qualifications needed to thrive in the FDA CBER position, and why are they important?

To thrive at FDA CBER (Center for Biologics Evaluation and Research), you need expertise in biological sciences, regulatory affairs, and data analysis, often supported by an advanced degree in a relevant scientific field. Familiarity with regulatory databases, clinical trial management systems, and guidance documents such as CFR Title 21 is crucial. Strong analytical, communication, and teamwork skills help you effectively evaluate product safety and efficacy while coordinating with diverse stakeholders. These abilities ensure that biologic products are rigorously reviewed for safety, quality, and compliance with federal regulations.

How to become an FDA CBER investigator?

To become an FDA CBER investigator, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or pharmacy, along with experience in regulatory science or biomedical research. Applicants must also pass the FDA's specialized training programs and meet security and background check requirements. Relevant skills include knowledge of biopharmaceutical products, inspection procedures, and regulatory compliance.
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Fda Cber jobs near you
Infographic showing various Fda Cber job openings in the United States as of August 2026, with employment types broken down into 82% Full Time, 9% Contract, and 9% Nights. Highlights an 73% In-person, and 27% Remote job distribution, with an average salary of $108,557 per year, or $52.2 per hour.

Senior Specialist, Cell Therapy Trade Compliance (FTZ)

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 11 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

24th of 86 rated pharmaceutical

Job description

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. In cell therapy, every movement matters. The reliable and compliant flow of patient materials, critical manufacturing inputs, intermediates, and finished product is essential to protecting product integrity, supporting manufacturing continuity, and helping therapies reach patients on time.
The Senior Specialist, Cell Therapy Trade Compliance - Free Trade Zone Operations plays a critical role in that mission by leading Free Trade Zone (FTZ) operations at AstraZeneca's cell therapy manufacturing sites. This role helps ensure materials can move compliantly, predictably, and with full traceability through import/export and FTZ processes, while maintaining strong inventory control, audit readiness, and alignment to vein-to-vein timelines and manufacturing schedules. This is an opportunity to work at the intersection of trade compliance, cell therapy logistics, and patient-centered operations, helping build the cross-border capabilities needed to support future growth and the next generation of personalized medicines.
You will be responsible for the day-to-day operation of FTZ activities that support the compliant movement and control of materials across the cell therapy network. You will work closely with Manufacturing, Supply Chain, Logistics, Quality, brokers, and external partners to ensure high execution quality, strong documentation practices, and reliable support for time-critical operations.
Key Responsibilities
  • Lead FTZ operations and compliance: Manage FTZ execution in line with 19 CFR Part 146 (Foreign Trade Zones), internal procedures, and site requirements, including admissions, status elections, zone-to-zone transfers, removals, exports, weekly entries, and annual reconciliation activities.
  • Support compliant material controls: Help ensure FTZ-compliant storage and movement of patient-specific materials and critical raw materialswith strong attention to traceability, segregation, documentation accuracy, and operational control.
  • Maintain Inventory, controland audit-ready records: Operate and maintain accurate FTZ inventory records within approved systems, support cycle counts and reconciliations, and ensure documentation is complete and compliance, and manage access controls.
  • Coordinate import execution and broker activities: Review and support import documentation and entry activities, including alignment to HTS classification, valuation, origin, and FDA/CBER import requirements, while partnering with customs brokers and internal stakeholders to resolve issues quickly and compliantly.
  • Support outbound FTZ shipment execution: Coordinate outbound movements from the FTZ for intermediates and finished product, ensuring documentation, customs processes, and shipment controls are completed accurately and on time.
  • Partner cross-functionally to support patient and manufacturing timelines: Work closely with Manufacturing, Quality, Supply Chainto align FTZ activities with batch release and patient schedules.
  • Track performance and identify improvement opportunities: Monitor KPIs such as inventory accuracy, admission cycle time, entry accuracy, customs holds, and exception trends, and support root cause analysis and corrective actions that improve reliability, compliance, and operational efficiency.
  • Maintain procedures and support training: Help develop and maintain SOPs, work instructions, and role-based training materials for FTZ and import/export processes, while supporting knowledge sharing and consistent execution across the network.

Essential Qualifications
  • Bachelor's degree in Supply Chain, International Business, Logistics, Life Sciences, or a related field.
  • 5+ Years experience in customs brokerage, import/export operations, trade compliance, or global logistics, including hands-on experience with FTZ or bonded operations.
  • Strong working knowledge of FTZ operations, customs documentation, broker coordination, and import/export execution.
  • Familiarity with 19 CFR Part 146, HTS classification, customs valuation, and FDA/CBER import requirements.
  • Experience working in a regulated environment; experience in biopharma, advanced therapies, or temperature-controlled logistics is preferred.
  • Experience maintaining accurate records, supporting audits or inspections, and working within controlled systems and documented procedures.
  • Attention to detail, ability to manage multiple priorities, and comfort working in a fast-paced and highly controlled operational environment.
  • Strong written and verbal communication skills, with the ability to work effectively across internal teams and external partners.
  • Proficiency in Excel and familiarity with inventory systems, broker portals, or logistics/trade systems.

Desirable Skills / Experience
  • Experience supporting cell therapy, biologics, advanced therapies, or other highly controlled healthcare logistics environments.
  • Familiarity with GDP, GMP, GxP, and documentation practices relevant to regulated logistics and trade operations.
  • Experience supporting temperature-controlled, cryogenic, or time-sensitive material movements.
  • Experience with operational reporting, KPI tracking, and continuous improvement activities.

#CellTherapy
The annual base pay for this position ranges from $89K to $134K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
19-Aug-2026
Closing Date
06-Sep-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.

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About AstraZeneca

Sourced by ZipRecruiter

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Make a meaningful impact that brings real benefits to society. By applying your knowledge of data, you will help to redefine our industry and ultimately save lives. Work with experts who share a common goal: to accelerate the potential of medicines and the science of tomorrow.

Industry

Pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Cambridge, Cambridgeshire, GB

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