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Regulatory Affairs Manager Jobs in Reston, VA (NOW HIRING)

Astrazeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as ...

AstraZeneca

Regulatory Affairs Director

Gaithersburg, MD · On-site

$162K - $213K/yr

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as ...

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All JobsRegulatory Affairs JobsRegulatory Affairs Manager JobsRegulatory Affairs Manager Jobs in Reston, VA

Regulatory Affairs Manager information

See Reston, VA salary details

$30

$59

$90

How much do regulatory affairs manager jobs pay per hour?

As of Sep 4, 2026, the average hourly pay for regulatory affairs manager in Reston, VA is $59.38, according to ZipRecruiter salary data. Most workers in this role earn between $43.85 and $69.42 per hour, depending on experience, location, and employer.

What does a regulatory affairs manager do?

A Regulatory Affairs Manager oversees the process of ensuring that a company’s products comply with all regulations and laws applicable to their industry, such as pharmaceuticals, medical devices, or food. They coordinate the preparation and submission of regulatory documents to government agencies and serve as a liaison between the company and regulatory authorities. Their role includes monitoring changes in regulations, developing strategies for approval, and ensuring ongoing compliance throughout the product lifecycle.

What does a regulatory affairs manager do?

As a regulatory affairs manager, your responsibilities entail ensuring that your employer observes all relevant laws and regulations. You can find employment in various sectors, including pharmaceutical, healthcare, and manufacturing industries. Your duties include compiling all necessary paperwork, evidence, and documentation to report to regulatory authorities. In addition to the management of paperwork and legal requirements, you help companies make operational and strategic decisions based on the regulations they are obligated to follow. You sometimes perform or coordinate audits to ensure compliance, and, in a large company, you oversee a staff of compliance specialists who handle various regulatory affairs tasks.

What are some common challenges faced by regulatory affairs managers when working with cross-functional teams?

Regulatory Affairs Managers often encounter challenges in aligning regulatory requirements with the goals of other departments, such as R&D, marketing, and manufacturing. Navigating differing priorities and timelines can be complex, especially when ensuring compliance without delaying product development. Effective communication and negotiation skills are essential to bridge gaps between teams, clarify regulatory expectations, and facilitate smooth collaboration. By proactively engaging stakeholders and providing regulatory guidance early in projects, Regulatory Affairs Managers can help teams work together more efficiently and avoid costly compliance issues.

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

To thrive as a Regulatory Affairs Manager, you need a comprehensive understanding of regulatory guidelines, scientific or technical expertise, and typically a degree in life sciences or a related field. Experience with submission management systems, regulatory databases, and knowledge of global regulatory frameworks (such as FDA, EMA, or ICH) are highly valuable. Strong attention to detail, communication skills, and the ability to manage cross-functional teams distinguish top performers in this role. These competencies are crucial for ensuring product compliance, minimizing approval risks, and facilitating smooth market entry.

What is the difference between Regulatory Affairs Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (e.g., RAC)Bachelor's degree, entry-level certifications
Work EnvironmentOversees teams, strategic planning, cross-department collaborationExecutes regulatory submissions, document preparation, detailed compliance tasks
Industry UsageUsed in pharmaceutical, biotech, medical device companies for leadership rolesCommonly found in similar industries, focusing on technical regulatory tasks
Search & Comparison IntentUnderstanding managerial responsibilities and scopeFocus on specific regulatory tasks and compliance details

The Regulatory Affairs Manager typically holds a leadership role, overseeing regulatory strategies and teams, while the Regulatory Affairs Specialist handles detailed compliance work and documentation. Both roles require relevant certifications and are essential in regulated industries like pharma and medical devices.

More about Regulatory Affairs Manager jobs

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Regulatory Affairs Manager jobs near you
Infographic showing various Regulatory Affairs Manager job openings in Reston, VA as of August 2026, with employment types broken down into 85% Full Time, 14% Part Time, and 1% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $123,274 per year, or $59.3 per hour.

Assoc. Regulatory Affairs Manager

Fladger Associates

Gaithersburg, MD • On-site

Contractor

Re-posted 25 days ago

Job description

Gaithersburg, MD
Contract Duration: 12-36 months
Rate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Assoc. Regulatory Affairs Manager in the Gaithersburg, MD area.
  • 100% Remote anywhere in the US - Candidate must be willing to work EST hours.
  • As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives.
  • The Gaithersburg site offers a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and healthy.
  • Company's vision in Oncology is to help patients by redefining the cancer-treatment paradigm.
  • A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers.
  • As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
  • Regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
  • The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated regulatory applications and leading procedures through approval.
  • The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory input and submission delivery strategy of all dossiers and all application types per market and/or region.
  • Reviews response documents, study protocols, PSRs, among others.
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more sophisticated submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates including regulatory risks and mitigation strategies to designated partners.
  • Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.
  • Provide coaching, mentoring and knowledge sharing within the team and contribute to process improvement.

Experience:

  • Relevant BS/BA Degree in Science or related field with 1-3 years of Regulatory experience within the Biopharmaceutical industry, or at a health authority, or other confirmed experience.
  • General knowledge of Drug Development.
  • Strong Project Management skills.
  • Leadership skills, including experience leading multi-disciplinary project teams
  • Preferred skills:
    • Led regulatory deliverables at the project level.
    • Detailed knowledge of the drug development process.
    • Knowledge of company Business and processes