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Regulatory Operations Associate Jobs in Maryland

AstraZeneca

Senior Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

May line manage, develop, and coach Regulatory Affairs Directors (RAD) and/or Associate Regulatory ... May be accountable for leadership of regulatory operational activities from planning to submission ...

AstraZeneca

Senior Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

May linemanage, develop, and coach Regulatory Affairs Directors (RAD) and/or Associate Regulatory ... May be accountable for leadership of regulatory operational activities from planning to submission ...

AstraZeneca

Senior Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

May line manage, develop, and coach Regulatory Affairs Directors (RAD) and/or Associate Regulatory ... May be accountable for leadership of regulatory operational activities from planning to submission ...

AstraZeneca

Senior Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

May line manage, develop, and coach Regulatory Affairs Directors (RAD) and/or Associate Regulatory ... May be accountable for leadership of regulatory operational activities from planning to submission ...

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Regulatory Operations Associate information

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$51

How much do regulatory operations associate jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for regulatory operations associate in Maryland is $25.47, according to ZipRecruiter salary data. Most workers in this role earn between $17.26 and $29.38 per hour, depending on experience, location, and employer.

What is a regulatory operations associate?

Regulatory Operations Associates are professionals who support the preparation, submission, and management of documents required by regulatory agencies for product approvals, especially in industries like pharmaceuticals, biotechnology, and medical devices. They ensure that submissions comply with legal and regulatory standards, track submission timelines, and often use specialized software for document management. Their work is crucial for maintaining compliance and facilitating smooth communication between their company and regulatory authorities. Additionally, Regulatory Operations Associates may coordinate with cross-functional teams to gather necessary documentation and maintain up-to-date records.

How does a regulatory operations associate typically collaborate with cross-functional teams within an organization?

Regulatory Operations Associates frequently work alongside regulatory affairs, quality assurance, clinical, and legal teams to ensure that all submissions and documentation comply with industry standards and governmental regulations. They coordinate the collection, formatting, and timely submission of regulatory documents, often acting as a liaison between departments to resolve any discrepancies or gather necessary information. Effective communication and organization are key, as the role requires balancing multiple deadlines and adapting to evolving requirements set by regulatory authorities.

What are the key skills and qualifications needed to thrive as a regulatory operations associate, and why are they important?

To excel as a Regulatory Operations Associate, you generally need a background in life sciences or a related field, strong attention to detail, and experience with regulatory documentation processes. Familiarity with electronic document management systems (EDMS), eCTD publishing tools, and knowledge of regulatory submission standards are typically required. Excellent organizational skills, communication, and the ability to manage multiple deadlines help candidates stand out. These competencies ensure accurate, timely regulatory submissions and compliance, which are critical for product approvals and organizational success.

What is the difference between Regulatory Operations Associate vs Regulatory Affairs Specialist?

AspectRegulatory Operations AssociateRegulatory Affairs Specialist
Required CredentialsBachelor's degree, familiarity with regulatory processesBachelor's degree, often with certifications in regulatory affairs
Work EnvironmentSupportive regulatory teams, administrative tasksStrategic planning, compliance management
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, medical device, biotech sectors
Common Search & ComparisonYesNo

The Regulatory Operations Associate typically handles administrative and operational support within regulatory teams, focusing on document management and submission processes. In contrast, the Regulatory Affairs Specialist is more involved in strategic compliance, ensuring products meet regulatory standards. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.

What are the most commonly searched types of Regulatory Operations jobs in Maryland?

The most popular types of Regulatory Operations jobs in Maryland are:

What are popular job titles related to Regulatory Operations Associate jobs in Maryland?

For Regulatory Operations Associate jobs in Maryland, the most frequently searched job titles are:

What job categories do people searching Regulatory Operations Associate jobs in Maryland look for?

The top searched job categories for Regulatory Operations Associate jobs in Maryland are:

What cities in Maryland are hiring for Regulatory Operations Associate jobs?

Cities in Maryland with the most Regulatory Operations Associate job openings:

Regulatory Operations Associate jobs near you
Infographic showing various Regulatory Operations Associate job openings in Maryland as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $52,980 per year, or $25.5 per hour.

Associate Director, Cell Therapy Trade Compliance Operations

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

23rd of 86 rated pharmaceutical

Job description

Associate Director, Cell Therapy Trade Compliance Operations
Introduction to role:
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. As our network, geographic footprint, and operational complexity continue to expand, trade compliance operations are increasingly critical to ensuring that patient materials, critical manufacturing inputs, intermediates, and finished product can move compliantly, predictably, and without avoidable delay across borders.
The Associate Director, Cell Therapy Trade Compliance Operations leads the operating model for import/export and Free Trade Zone (FTZ) execution across the cell therapy network. This role is responsible for building scalable, reliable, and compliant operational processes; leading first-line escalation and business continuity for cross-border execution; and strengthening broker performance, visibility, digitization, and standardization to support future growth and commercial readiness.
This role also provides people leadership for team members responsible for operational trade compliance execution and partners closely within Patient Supply Operations, Global Supply Chain, Quality, Regulatory, and Digital teams to ensure cross-border trade requirements strengthen the delivery system that supports patient and product journeys.
This role is a hybrid position with a requirement to work in the office three days a week.
Accountabilities:
  • Lead the trade compliance operating model for import/export and FTZ execution across the cell therapy network, including global execution rhythms, governance routines, escalation pathways, role clarity, and cross-site ways of working that support reliable daily operations.

  • Lead import/export and FTZ execution for patient materials, manufacturing inputs, intermediates, and finished product, ensuring compliant and timely execution of customs entry, shipment coordination, broker engagement, FTZ activity, and issue resolution in line with customs requirements, FDA/CBER import expectations, and internal procedures.

  • Own first-line escalation and continuity management for cross-border trade execution issues, including shipment holds, documentation issues, customs delays, broker performance concerns, and FTZ operational issues that may impact patient timelines, manufacturing continuity, or inventory control.

  • Drive process excellence and scalability across trade compliance operations through workflow simplification, bottleneck removal, standard work, and repeatable operating methods that support network expansion, increasing shipment volumes, and growing operational complexity.

  • Strengthen digital enablement and operational visibility by partnering with business and digital stakeholders to improve workflows, dashboards, KPI reporting, exception tracking, and data quality, reducing manual effort and enabling more scalable and data-driven trade compliance operations.

  • Own operational documentation and standard work for shipment execution, FTZ processes, broker coordination, escalation management, issue resolution, business continuity, and execution controls, ensuring SOPs, work instructions, playbooks, and training materials remain current, practical, and aligned to regulatory and business requirements.

  • Lead performance management and broker management for customs brokers, freight forwarders, and related service providers, including performance monitoring, service issue management, escalation handling, and operational input to scorecards and structured performance reviews.

  • Support network readiness and expansion for new countries, sites, lanes, products, and operating models by ensuring trade compliance execution requirements, broker readiness, documentation processes, and FTZ implications are understood and deployable.

  • Use data to improve operational performance by tracking trends and risks across customs clearance, shipment holds, broker performance, FTZ execution, and exception resolution, and by driving corrective actions that improve predictability, compliance, and service reliability.

  • Provide strong people leadership, building and leading a high-performing team through clear direction, role clarity, workload prioritization, coaching, development, and performance management to ensure strong execution quality, accountability, collaboration, and effective network coverage.

Essential Skills/Experience:
  • Minimum education: a Bachelor's degree in Supply Chain, International Business, Life Sciences, Logistics, Engineering, or a related field.
  • 8+ years of experience in customs brokerage, import/export operations, trade compliance, global logistics, or supply chain operations in a regulated environment
  • Strong experience with FTZ or bonded operations, customs entry processes, broker governance, and import/export execution
  • Demonstrated experience leading operating models, process improvement, digitization, and scalable business processes
  • Clear communication, stakeholder management, sound judgment, and the ability to lead within a matrixed organization are essential.

Desirable Skills/Experience:
  • Advanced degree such as MS, MBA, or equivalent.
  • Experience supporting clinical-to-commercial transition, global expansion, country enablement, or network scale-up in a complex supply environment.
  • Experience with Excel, Power BI, Tableau, Smartsheet, or similar tools for reporting, workflow management, and operational visibility.
  • Experience supporting time-critical, cryogenic, temperature-controlled, or highly specialized logistics operations.
  • Working knowledge of GDP, GxP, and regulated logistics practices relevant to cross-border execution in biopharma environments.

The annual base pay (or hourly rate of compensation) for this position ranges from 115,919.2 to 173878.8 USD. 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.
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, you are trusted to take accountability and make change real-pairing scientific ambition with digital innovation to speed therapies to patients. You will work with expert partners across disciplines, using data, automation, and practical problem-solving to reimagine how critical materials flow through a complex, regulated network. We move decisively and learn fast, valuing kindness alongside ambition, so you can contribute boldly, grow your craft, and see the impact of your decisions reflected in patient outcomes and enterprise progress.
Call to Action:
If you are ready to design, lead, and scale a disciplined, data-driven trade compliance operation that keeps cell therapies moving to patients, take the next step and share your story with us today.
#LI-Hybrid
Date Posted
30-Jul-2026
Closing Date
30-Aug-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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