Regulatory Submissions Remote Jobs

Find remote jobs requiring Regulatory Submissions skills. Apply now and work from anywhere.

Regulatory Submissions means preparing and sending the documents regulators need to approve a product or change. That often includes compiling clinical and safety data, writing summaries, assembling labeling and technical files, and responding to questions from authorities. The goal is clear, complete records that support a product’s safety and claims.

This skill fits well with remote work because much of the work is document based and can be done online. Teams coordinate across time zones, share documents in secure systems, and communicate by email and video. Strong organization, clear writing, and timely responses matter more than being in an office, so people who can manage files, timelines, and cross-functional reviews thrive remotely.

Industries that need regulatory submission skills include:

  • Pharmaceuticals and biologics
  • Medical devices and diagnostics
  • Vaccine development and clinical research
  • Food, dietary supplements, and cosmetics with health claims
  • Chemicals, veterinary products, and regulatory consulting firms

To develop this skill, start by learning the basics of regulatory requirements and common submission formats. Practice writing clear summaries and building dossiers from source documents. Get comfortable with document management systems and version control, and join regulatory affairs courses or professional groups. Hands-on experience through internships, volunteer projects, or working with cross-functional teams will build practical knowledge. Above all, focus on attention to detail, communication, and a habit of keeping up with guidance changes.

Clinical Research Associate II

Oxford, United Kingdom
1 day ago
Clinical Monitoring
Clinical Trial Communication
Microsoft Office (Intermediate/Advanced)
PSI CRO
Full-Time
Experienced

Clinical Research Associate II

Madrid, Spain
3 weeks ago
Communication
GCP
On-site Monitoring
Ergomed
Full-Time
Experienced

Senior Clinical Research Associate

San Fransisco, California
4 weeks ago
Clinical Monitoring
Oncology Or Rare Disease Experience
Phase II/III Trials
Ergomed
Full-Time
Senior Manager

Product Quality Lead

Morrisville, NC or San Diego, CA
1 month ago
GMP/GDP Compliance
Leadership
Product Lifecycle Management
Sobi
Full-Time
Senior Manager
YEAR $125000 - $165000

Regulatory Officer

São Paulo, Brazil
1 month ago
ANVISA (Brazil) Submissions
Attention To Detail
Clinical Trial Documentation
PSI CRO
Full-Time
Experienced

Director, Global Regulatory Affairs

Chicago, IL
3 months ago
CMC/Clinical Regulatory Knowledge
Health Authority Interactions
Project Management
EVERSANA
Full-Time
Senior Manager

Senior Clinical Research Associate

West Coast, USA
3 months ago
Clinical Monitoring
Oncology Clinical Trials
Regulatory Submissions
PSI CRO
Full-Time
Senior Manager

Director, Statistical Sciences

Waltham, MA
3 months ago
Biostatistics
Clinical Trial Design
Leadership & Team Management
Sobi
Full-Time
Senior Manager
YEAR $175000 - $240000

Account Manager

Milan, Italy
4 months ago
Account Management
Client Communication
Financial Management
EVERSANA
Full-Time
Experienced

Medical Director, Clinical Science

Boston, MA
4 months ago
Clinical Development
Immunology
Medical Monitoring
Sobi
Full-Time
Senior Manager
YEAR $190000 - $270000

Medical Director, Clinical Science

Boston, MA
4 months ago
Clinical Development
Clinical Trials Management
Immunology/Critical Care Expertise
Sobi
Full-Time
Senior Manager
YEAR $190000 - $270000

Senior Clinical Research Associate

Montreal, Canada
5 months ago
Clinical Data Management
Communication
On-site Monitoring
PSI CRO
Full-Time
Experienced

Senior Clinical Research Associate

Remote, West Coast
5 months ago
Clinical Monitoring
CRF Review
Oncology Trial Monitoring
PSI CRO
Full-Time
Experienced

Senior CRA I

Toronto, Canada
6 months ago
Clinical Study Management
Communication
CRF Review
PSI CRO
Full-Time
Experienced

Medical Director, Ophthalmology

USA
6 months ago
Clinical Research
Data Analysis
Medical Monitoring
4D Molecular Therapeutics
Full-Time
Manager
YEAR $275000 - $340000

Clinical Research Associate II

Remote, undefined
6 months ago
Clinical Monitoring
Investigational Product Handling
On-site Monitoring
PSI CRO
Full-Time
Experienced

Medical Writer

USA
6 months ago
Clinical Documentation
Cross-functional Collaboration
Medical Writing
PTF Consulting, LLC
Full-Time
Manager

Medical Writing Operations Manager

USA
6 months ago
GXP
Medical Writing Operations
Regulatory Submissions
Kyverna
Contractor
Manager
HOUR $70 - $80

Senior Clinical Research Associate

Remote, West Coast
7 months ago
Clinical Monitoring
Communication Skills
Oncology Trial Experience
PSI CRO
Full-Time
Experienced

Senior CRA

Vancouver, Canada
7 months ago
Clinical Monitoring
CRF Review
Regulatory Submissions
PSI CRO
Full-Time
Experienced

Senior Medical Writer

USA
7 months ago
Clinical Study Protocols
Clinical Study Reports (CSRs)
Medical Writing
Spyretherapeutics
Full-Time
Experienced
YEAR $130000 - $145000

Principal Medical Writer

Waltham, MA
7 months ago
Clinical Study Reports
ECTD
ICH Guidelines
Deciphera Pharmaceuticals
Full-Time
Experienced
YEAR $164000 - $226000

Senior Clinical Research Associate

Kuala Lumpur, Malaysia
8 months ago
Clinical Monitoring
Communication
Regulatory Submissions
PSI CRO
Full-Time
Experienced

Executive Director, Medical Writing

USA
8 months ago
Clinical Research
Medical Writing
Project Management
MapLight Therapeutics
Full-Time
Manager

Senior Clinical Research Associate

Kuala Lumpur, Malaysia
8 months ago
Clinical Monitoring
Clinical Trial Management
Communication
PSI CRO
Full-Time
Experienced

Site Management Associate I

Bogotá, Colombia
8 months ago
Clinical Research
Communication
Regulatory Submissions
PSI CRO
Full-Time
Entry Level

Staff Medical Writer

USA
9 months ago
Clinical Evaluation Reports (CERs)
EU-MDR
Medical Writing
Stryker Employment Company, LLC
Full-Time
Experienced
YEAR $87600 - $186700

Principal Medical Writer, Global Medical Writing

Waltham, MA
9 months ago
Attention To Detail
Clinical Study Protocols
Knowledge Of Clinical Trial Disclosure
Deciphera Pharmaceuticals
Full-Time
Experienced
YEAR $164000 - $226000

Senior Regulatory Affairs Specialist - International

Palo Alto, CA
9 months ago
IVD
Project Management
Regulatory Affairs
Guardant Health
Full-Time
Experienced
YEAR $112400 - $154550

Senior Regulatory Affairs Manager - Oncology

Palo Alto, CA
9 months ago
Cross-functional Coordination
FDA Regulatory Submissions
IVD/CDx Development
Guardant Health
Full-Time
Senior Manager
YEAR $174300 - $239600

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