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Regulatory Submissions Jobs (NOW HIRING)

5TH HQ LLC

Regulatory Affairs

Fort Lauderdale, FL · On-site

$19 - $20/hr

Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies. * Assist in the development and implementation of regulatory strategies to support product approvals ...

Jobtailor

Director/Sr. Director, Regulatory CMC

Boston, MA · On-site

$180 - $240/hr

Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines * Act ...

New

Neuralink

Regulatory Engineer

Austin, TX · On-site

Prepare high-quality regulatory submissions (IDE, PMA, international equivalents, supplements, dossiers, etc.) by organizing technical evidence, preclinical data, clinical results, and other ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies * Plays a key role in ...

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Regulatory Submissions information

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$18

$39

$62

How much do regulatory submissions jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for regulatory submissions in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are regulatory submissions?

Regulatory submissions are formal documents or packages of information that organizations, such as pharmaceutical or medical device companies, submit to government agencies to obtain approval for products, clinical trials, or changes to existing products. These submissions must comply with specific regulatory requirements and formats, and may include data on safety, efficacy, quality, and manufacturing processes. Common regulatory agencies include the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others, depending on the region. The process helps ensure that products are safe and effective for public use before they reach the market.

What are some common challenges faced by professionals working in regulatory submissions?

Regulatory Submissions professionals often navigate complex and evolving regulations across different regions, which can be challenging when preparing documentation for multiple authorities. Managing tight deadlines, coordinating input from cross-functional teams (such as clinical, quality, and legal departments), and ensuring data accuracy are key aspects of the role. Additionally, adapting to varying submission formats and requirements for each regulatory body demands strong attention to detail and organizational skills. Overcoming these challenges is essential to facilitate timely product approvals and maintain compliance.

What are the key skills and qualifications needed to thrive in regulatory submissions, and why are they important?

To thrive in Regulatory Submissions, you need a strong understanding of regulatory guidelines, document management, and scientific or clinical background, often supported by a degree in life sciences or a related field. Familiarity with electronic submission platforms (eCTD), regulatory databases, and tools like Adobe Acrobat and Microsoft Office is typically required. Attention to detail, organizational skills, and effective written and verbal communication set professionals apart in this role. These skills ensure accurate, timely submissions and facilitate compliance with global regulatory requirements, which is critical for product approvals and company success.

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

AspectRegulatory SubmissionsRegulatory Affairs Specialist
Primary RolePreparing, submitting, and managing regulatory documents to authoritiesDeveloping regulatory strategies, ensuring compliance, and liaising with agencies
Required CredentialsTypically degrees in life sciences, certifications like RACSimilar credentials, often with additional experience in regulatory strategy
Work EnvironmentRegulatory departments within pharmaceutical or biotech companiesRegulatory teams across industries, including healthcare and medical devices

While Regulatory Submissions focus on preparing and managing specific documents for approval, Regulatory Affairs Specialists oversee broader compliance strategies and interactions with regulatory agencies. Both roles require similar credentials and often work closely within the same industry, but their scope and responsibilities differ.

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Regulatory Submissions jobs near you
Infographic showing various Regulatory Submissions job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Sr Regulatory Affairs Specialist

Foundation Medicine

Boston, MA • Hybrid

$101K - $126K/yr

Full-time

Posted 3 days ago

New

Job description

About the Job:

The Senior Specialist, Regulatory Affairs (CDx) performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for regulatory agencies and ensures compliance with all requirements.

Key Responsibilities:

  • Represent the regulatory affairs function on assigned cross-functional project teams.
  • Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market.
  • Write, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to:
  • Significant Risk Determination Requests (SRDs);
    • IDE applications;
    • Q-Submissions;
    • Pre-market applications (PMAs, sPMAs); and,
    • Performance Study Applications
  • Support and eventually manage interactions with regulatory agencies including responses to regulatory inspections and regulatory submissions.
  • Support companion diagnostic regulatory strategy (analytical and clinical validation) and regulatory filings.
  • Review validation protocols and reports for regulatory submission soundness.
  • Publish electronic regulatory submissions.
  • Represent FMI before regulatory authorities and biopharmaceutical partners on regulatory and technical matters, as needed.
  • Provide support for marketed products, e.g., review engineering changes, labeling, promotional material, and product changes for compliance.
  • Support change control activities that require regulatory agency approval per US regulatory requirements.
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
  • Draft submission documents with other subject matter experts as needed.
  • Review and edit technical documents to be included in submission, which may include software validation protocols and reports and/or other software development documentation.
  • Other duties as assigned.
  • Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

  • Bachelor's Degree and 3+ years of professional work experience; OR,
  • Master's Degree and 1+ year(s) of professional work experience

Preferred Qualifications:

  • Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting pre-sub, IDE application and/or PMA documents to FDA and other health authorities
  • Professional and/or academic experience:
    • interpreting scientific data, including clinical data
    • successfully managing multiple concurrent regulatory submissions
    • working cross-functionally on complex projects involving assay, instrumentation and software
    • attending meetings with FDA
  • Experience with companion diagnostics
  • Expertise in regulatory strategy
  • Regulatory compliance knowledge of FDA IVD requirements and understanding of validation design typical for FDA IVD submissions
  • Familiarity with device design control process and regulatory role in process
  • Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration and problem-solving
  • Strong attention to detail and organizational skills
  • Understanding of HIPAA and the importance of patient data privacy
  • Commitment to reflect FMI's values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $101,440 - $126,800 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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