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Remote Fda Jobs in Malden, MA (NOW HIRING)

Qualio

Account Executive (Remote)

Boston, MA · Remote

... and FDA requirements. Qualio is ISO 27001, ISO 9001, and ISO 27701 certified, reflecting our ... The Qualio team is all-remote, and currently distributed across North America, Europe and Australia.

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65 - $85/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

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All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Malden, MA

Remote Fda information

What is a remote FDA?

A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.

What are the typical daily responsibilities of a remote FDA compliance specialist?

A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.

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

To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.

What jobs can I do completely remotely as a remote FDA?

A remote FDA typically refers to a Food and Drug Administration-related role that can be performed remotely, such as regulatory affairs specialists, quality assurance managers, or compliance analysts. These positions often require knowledge of regulations, strong communication skills, and familiarity with digital tools for document review and reporting, allowing work to be done entirely online. However, some roles may require occasional on-site visits or inspections depending on the specific job and employer policies.

What are the most commonly searched types of Fda jobs in Malden, MA?

The most popular types of Fda jobs in Malden, MA are:

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For Remote Fda jobs in Malden, MA, the most frequently searched job titles are:

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Remote Fda jobs near you

NDA Regulatory Strategy Consultant (Remote)

Boston, MA • Remote

The FDA Group
Recruiting and Staffing Services • 11 - 50 employees
Learn more about The FDA Groupexternal

Full-time

Posted 9 days ago

Job description

NDA Regulatory Strategy Consultant

Location: Fully Remote
Work Arrangement: Remote
Start: Late Q4 2026 / Early Q1 2027
Schedule: Approximately 20 hours per week

Position Overview

We are seeking an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of New Drug Application (NDA) preparation for a life sciences organization.

The consultant will serve as a key regulatory advisor, providing overall strategic oversight of the NDA dossier and helping ensure the submission is complete, consistent, and positioned for FDA readiness. This individual will work closely with the existing regulatory project manager, regulatory writers, and internal stakeholders to review submission content, identify gaps and compliance risks, and maintain consistent regulatory messaging across the dossier.

This is a strategic but hands-on role requiring substantial direct NDA submission experience and the ability to operate independently with minimal guidance. The consultant may also serve as an interim senior regulatory lead while the organization recruits a permanent employee.

Key Responsibilities

  • Provide senior-level strategic oversight of the NDA dossier during final preparation.
  • Guide overall regulatory strategy and help ensure consistent messaging across the submission.
  • Review NDA content for completeness, consistency, compliance risks, and FDA readiness.
  • Identify regulatory gaps and recommend appropriate actions to address issues prior to submission.
  • Work closely with the regulatory project manager, writers, and internal team to maintain alignment across submission activities.
  • Provide practical regulatory guidance and decision support throughout the final stages of NDA preparation.
  • Apply hands-on NDA submission experience to anticipate potential FDA concerns and strengthen submission readiness.
  • Operate independently as a senior regulatory advisor with minimal oversight.
  • Potentially serve as an interim senior regulatory lead until a permanent regulatory employee is hired.

Required Qualifications

  • Significant hands-on experience preparing and supporting NDA submissions.
  • Strong knowledge of FDA regulatory expectations applicable to NDA preparation and submission.
  • Demonstrated ability to provide strategic oversight of complex regulatory dossiers.
  • Experience reviewing submission content, identifying regulatory gaps and compliance risks, and supporting FDA readiness.
  • Ability to collaborate effectively with regulatory project management, writing, and cross-functional internal teams.
  • Ability to operate independently and provide senior-level regulatory guidance with minimal direction.

Ideal Candidate

The ideal consultant is a seasoned regulatory professional with substantial hands-on NDA submission experience who can quickly step into a senior advisory role. This individual will combine strategic regulatory judgment with detailed dossier review capabilities and be comfortable serving as a trusted regulatory lead during a critical stage of submission preparation.