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$16

$32

$48

How much do regulatory associate jobs pay per hour?

As of May 28, 2026, the average hourly pay for regulatory associate in Frederick, MD is $32.02, according to ZipRecruiter salary data. Most workers in this role earn between $24.38 and $37.98 per hour, depending on experience, location, and employer.

What Does a Regulatory Associate Do?

As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.

What are the key skills and qualifications needed to thrive as a Regulatory Associate, and why are they important?

To thrive as a Regulatory Associate, you need strong attention to detail, knowledge of regulatory guidelines (such as FDA or EMA), and a relevant degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and electronic common technical document (eCTD) software is typically required. Excellent organizational skills, communication abilities, and the capacity to manage deadlines make candidates stand out. These skills ensure accurate regulatory submissions, compliance with evolving regulations, and effective collaboration across teams, all of which are crucial for product approvals and market access.

What are some common challenges Regulatory Associates face when working with cross-functional teams?

Regulatory Associates often work closely with teams from R&D, quality assurance, clinical, and legal departments to ensure compliance throughout product development and approval processes. A common challenge is navigating differing priorities and timelines among these groups, which requires strong communication and organizational skills. Additionally, Regulatory Associates must interpret and clarify complex regulatory requirements to various stakeholders, ensuring everyone is aligned and informed. Building collaborative relationships and proactively addressing potential misunderstandings are key to overcoming these challenges.

What is a Regulatory Associate?

A Regulatory Associate is a professional who supports regulatory affairs teams in ensuring that a company complies with all relevant laws and regulations, particularly in industries like pharmaceuticals, biotechnology, and medical devices. They assist in preparing, submitting, and maintaining regulatory filings and documentation required by government agencies. Regulatory Associates also help track changes in regulations and support product development by ensuring all necessary approvals are obtained for products to enter the market.

What is the difference between Regulatory Associate vs Compliance Specialist?

AspectRegulatory AssociateCompliance Specialist
Required CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plusBachelor's degree in law, business, or related; certifications like CCEP may be relevant
Work EnvironmentPharmaceutical, biotech, or medical device companies; regulatory departmentsCorporate compliance departments across various industries, including healthcare and finance
Employer & Industry UsageUsed in regulated industries to prepare and submit regulatory documentsUsed to ensure company adherence to laws and regulations, often involving audits and policy development

The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.

More about Regulatory Associate jobs
What are the most commonly searched types of Regulatory jobs in Frederick, MD? The most popular types of Regulatory jobs in Frederick, MD are:
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What job categories do people searching Regulatory Associate jobs in Frederick, MD look for? The top searched job categories for Regulatory Associate jobs in Frederick, MD are:
What cities near Frederick, MD are hiring for Regulatory Associate jobs? Cities near Frederick, MD with the most Regulatory Associate job openings:
Regulatory Associate jobs near you
Infographic showing various Regulatory Associate job openings in Frederick, MD as of May 2026, with employment types broken down into 1% As Needed, 89% Full Time, 7% Part Time, and 3% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $66,608 per year, or $32 per hour.

Assoc. Regulatory Affairs Manager

Fladger Associates

Gaithersburg, MD • On-site

Contractor

Posted 16 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