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Remote Regulatory Writing Jobs in New Jersey (NOW HIRING)

Taiho Oncology

$141.95K - $167K/yr

Remote Employee Value Proposition: At Taiho Oncology, the compassion we practice for our patients ... The Manager, Medical Writing is accountable for the timely delivery of high quality, regulatory ...

taiho

Manager, Medical Writing

Princeton, NJ · On-site +1

$141.95K - $167K/yr

Remote Employee Value Proposition: At Taiho Oncology, the compassion we practice for our patients ... The Manager, Medical Writing is accountable for the timely delivery of high quality, regulatory ...

FreightTAS LLC

Customs Entry Writer

Elizabeth, NJ · On-site +1

$50K - $75K/yr

... Remote Option: No About Us We're a trusted mid-sized Customs Brokerage firm with over 40 years of ... S. Customs regulations * Support various office and client-facing correspondence * Provide ...

FreightTAS LLC

Customs Entry Writer

Secaucus, NJ · On-site +1

$50K - $75K/yr

... Remote Option: No About Us We're a trusted mid-sized Customs Brokerage firm with over 40 years of ... S. Customs regulations * Support various office and client-facing correspondence * Provide ...

FreightTAS LLC

Customs Entry Writer

Springfield, NJ · On-site +1

$50K - $75K/yr

... Remote Option: No About Us We're a trusted mid-sized Customs Brokerage firm with over 40 years of ... S. Customs regulations * Support various office and client-facing correspondence * Provide ...

FreightTAS LLC

Customs Entry Writer

Elizabeth, NJ · On-site +1

$50K - $75K/yr

... Remote Option: No About Us We're a trusted mid-sized Customs Brokerage firm with over 40 years of ... S. Customs regulations * Support various office and client-facing correspondence * Provide ...

Pharmacy Careers

Appeals Pharmacist (Remote)

Lakewood, NJ · On-site +1

$56.50 - $68.75/hr

Excellent clinical judgment, written communication, and attention to regulatory detail. Why This ... Many roles offer hybrid or fully remote options. * Rewards: Competitive salary, comprehensive ...

Pharmacy Careers

Appeals Pharmacist (Remote)

Passaic, NJ · On-site +1

$59.25 - $72.25/hr

Excellent clinical judgment, written communication, and attention to regulatory detail. Why This ... Many roles offer hybrid or fully remote options. * Rewards: Competitive salary, comprehensive ...

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Remote Regulatory Writing information

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

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What are popular job titles related to Remote Regulatory Writing jobs in New Jersey? For Remote Regulatory Writing jobs in New Jersey, the most frequently searched job titles are:
What job categories do people searching Remote Regulatory Writing jobs in New Jersey look for? The top searched job categories for Remote Regulatory Writing jobs in New Jersey are:
What cities in New Jersey are hiring for Remote Regulatory Writing jobs? Cities in New Jersey with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you
Infographic showing various Remote Regulatory Writing job openings in New Jersey as of May 2026, with employment types broken down into 1% As Needed, 90% Full Time, 7% Part Time, and 2% Contract. Highlights an 38% Physical, 2% Hybrid, and 60% Remote job distribution.
Director, Regulatory Affairs - Infectious Disease

Director, Regulatory Affairs - Infectious Disease

Tonix Pharmaceuticals

Berkeley Heights, NJ • On-site, Remote

$156.50K - $206.60K/yr

Other

Posted 16 days ago

Job description

Position Overview

The Director, Regulatory Affairs for Infectious Diseases will serve as the primary Regulatory Lead for Tonix's infectious disease biologics programs. This role oversees global regulatory strategy, submissions, health authority interactions, and crossfunctional leadership from early development (nonclinical, preIND) through clinical stages. The ideal candidate is proactive, strategic, and comfortable operating with minimal oversight while driving timelines and influencing team direction. This position will report directly to the Head of Regulatory Affairs and will be based at a Tonix office or can be a remote-based position.

Essential Duties

  • Serve as Regulatory Lead for biologics, focused on infectious diseases programs.
  • Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
  • Lead preparation, authorship, and coordination of regulatory submissions, including preIND packages, INDs, amendments, and briefing documents.
  • Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
  • Lead crossfunctional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
  • Assess regulatory risks, impacts, and mitigation options; communicate recommendations to internal teams and senior leadership.
  • Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.
  • Oversee regulatory documentation quality and timely delivery of program milestones.

Necessary Skills and Abilities

  • Strong scientific foundation in immunology, infectious diseases, or related biological disciplines.
  • Proven experience preparing and submitting INDs and related earlyphase regulatory documents.
  • Demonstrated ability to independently lead regulatory strategy and crossfunctional teams.
  • Strong knowledge of FDA, ICH, EU, and applicable global regulatory guidelines.
  • Excellent written and verbal communication skills, including regulatory writing and team communication.
  • Strong organizational, planning, and prioritization skills with high attention to detail.
  • Ability to manage multiple responsibilities in a fastpaced, dynamic environment.
  • Ability to work independently with minimal oversight while collaborating effectively across functions.
  • Ability to travel up to 20%.

Educational Requirements

  • Bachelor's degree in biological sciences, pharmaceutical sciences, or related field; advanced degree preferred.

Experience Requirements

  • 10-12+ years of progressively responsible regulatory experience with demonstrated program leadership.

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