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Remote Fda Jobs in Apex, NC (NOW HIRING)

... HR OPEN to remote candidates * ssist Regulatory Personnel with the Completion of Work Packages for Development Projects: o Draft Meeting Requests and Briefing Packages for FDA meetings ...

... HR OPEN to remote candidates * ssist Regulatory Personnel with the Completion of Work Packages for Development Projects: o Draft Meeting Requests and Briefing Packages for FDA meetings ...

Remote Schedule: Full-Time | Eastern Time Zone Hours Pay: $62.00-$64.73 per hour Position Overview ... Strong understanding of ICH/GCP, FDA guidelines, and clinical trial requirements . * Experience ...

... the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for clients. You ... This is a remote role but may require onsite visits to clients. Job Responsibilities: * Represent ...

... the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for clients. You ... This is a remote role but may require onsite visits to clients. Job Responsibilities: * Represent ...

Compliance Officers

Durham, NC · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Compliance Officers

Cary, NC · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Biostatistician

Raleigh, NC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Biostatistician

Durham, NC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Director of Biostatistics

Cary, NC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Biostatistician

Cary, NC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Experience preparing submission-ready deliverables for regulatory agencies (e.g., FDA, EMA) is a ...

Compliance Officers

Raleigh, NC · Remote

$50 - $80/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

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Showing results 1-20

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 job categories do people searching Remote Fda jobs in Apex, NC look for?

The top searched job categories for Remote Fda jobs in Apex, NC are:

What cities near Apex, NC are hiring for Remote Fda jobs?

Cities near Apex, NC with the most Remote Fda job openings:

Infographic showing various Remote Fda job openings in Apex, NC as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution.

Regulatory Affairs Specialist

AA2IT

Raleigh, NC • Remote

$28 - $30/hr

Full-time

This job post has expired today. Applications are no longer accepted.


Job description

HCR0003161
Title - Regulatory Affairs Specialist
Location - Remote
Pay Rate - $28-30/HR

OPEN to remote candidates

  • ssist Regulatory Personnel with the Completion of Work Packages for Development Projects: o Draft Meeting Requests and Briefing Packages for FDA meetings, Investigational New Drug Applications, Supplemental Biologic License Applications, Supplements to Marketing Applications (Labeling, Efficacy, and CMC), Pediatric Study Plans, Orphan Drug Applications, Clinical Trial Supporting Documents (Protocol Amendments, Investigator Updates, Investigator's Brochure, harmonization request, IND Safety Reports).
  • ssist Regulatory Personnel with Labeling and Artwork Maintenance: o Review and perform quality checks of labeling and artwork updates for all products." Kindly share updated resume with answers: Q1: How many years of exp in A: Regulatory Affairs B: FDA submissions C: IND / BLA D: CMC documentation E: Labeling review F: Artwork review G: Clinical regulatory support H Regulatory operations Q2: Are you open to work remote and open for 4-6 months work