ZipRecruiter

Log In

1

Pharma Regulatory Publishing Jobs (NOW HIRING)

Hippocratic AI

Director, Regulatory

Menlo Park, CA · On-site

$220 - $320/hr

Develop and publish thought leadership on AI in pharma commercialization -- including perspectives ... Identify emerging regulatory trends in AI‑enabled healthcare and patient engagement, and advise ...

Hippocratic AI

Director, Regulatory

Menlo Park, CA · On-site

$176K - $233K/yr

Develop and publish thought leadership on AI in pharma commercialization - including perspectives ... Identify emerging regulatory trends in AI-enabled healthcare and patient engagement, and advise ...

AbbVie

Statistical Programmer (Hybrid)

North Chicago, IL · On-site

$65K/yr

Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and ... Pharma experience Additional Information Applicable only to applicants applying to a position in ...

krg technology inc

Project Manager

Rahway, NJ · On-site

Pharma IT, GxP Project, PMP Certification Domain Experience Working knowledge of ICH Guidelines and ... Life Sciences regulations Technical Experience Experience with LIQUENT Insight publisher, Veeva ...

next page

Showing results 1-20

All JobsPharma Regulatory Publishing Jobs

Pharma Regulatory Publishing information

See salary details

$34K

$59K

$114.5K

How much do pharma regulatory publishing jobs pay per year?

As of Aug 25, 2026, the average yearly pay for pharma regulatory publishing in the United States is $58,981.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,000.00 per year, depending on experience, location, and employer.

What is Pharma Regulatory Publishing?

Pharma Regulatory Publishing is the process of preparing, formatting, and submitting regulatory documents required by health authorities for drug approval, such as the FDA or EMA. It involves converting scientific and clinical data into compliant electronic or paper submissions, ensuring that documentation meets specific technical and regulatory standards. Professionals in this field use specialized software and must stay updated on the latest submission requirements and guidelines. Their work is crucial for ensuring that new drugs can be reviewed efficiently and brought to market safely.

What are some common challenges faced in Pharma Regulatory Publishing, and how can new professionals prepare for them?

Professionals in Pharma Regulatory Publishing often encounter tight deadlines, rapidly changing global submission requirements, and the need to manage large volumes of complex documents. Attention to detail and strong organizational skills are crucial, as errors or inconsistencies can delay approvals. New professionals can prepare by familiarizing themselves with regulatory guidelines (such as CTD/eCTD formats), mastering relevant software tools, and developing effective communication skills for collaborating with cross-functional teams like regulatory affairs, medical writing, and quality assurance.

What are the key skills and qualifications needed to thrive as a Pharma Regulatory Publishing professional, and why are they important?

To thrive in Pharma Regulatory Publishing, you need a solid understanding of regulatory guidelines (such as ICH, FDA, and EMA requirements), document management, and a background in life sciences or pharmaceuticals. Familiarity with electronic submission tools like eCTD, publishing software (e.g., Lorenz docuBridge, Extedo eCTDmanager), and document tracking systems is typically required. Attention to detail, strong organizational skills, and effective communication are vital soft skills for ensuring submission accuracy and collaborating across teams. These competencies are crucial to ensure timely, compliant submissions that support product approvals and maintain regulatory compliance.

What is the difference between Pharma Regulatory Publishing vs Pharma Regulatory Affairs Specialist?

AspectPharma Regulatory PublishingPharma Regulatory Affairs Specialist
Primary FocusPreparing, formatting, and managing regulatory documents and submissionsDeveloping regulatory strategies, ensuring compliance, and liaising with authorities
Required SkillsTechnical writing, document management, attention to detailRegulatory knowledge, communication skills, strategic planning
Work EnvironmentDocument teams, regulatory departments, often in pharmaceutical companies or CROsRegulatory departments, cross-functional teams, often in pharma companies

Pharma Regulatory Publishing primarily involves managing and formatting regulatory documents for submission, focusing on technical accuracy. In contrast, Pharma Regulatory Affairs Specialists develop strategies and ensure compliance with regulations. While both roles require regulatory knowledge, publishing roles emphasize document management, whereas specialists focus on regulatory strategy and communication.

More about Pharma Regulatory Publishing jobs

What cities are hiring for Pharma Regulatory Publishing jobs?

Cities with the most Pharma Regulatory Publishing job openings:

What states have the most Pharma Regulatory Publishing jobs?

States with the most job openings for Pharma Regulatory Publishing jobs include:

What job categories do people searching Pharma Regulatory Publishing jobs look for?

The top searched job categories for Pharma Regulatory Publishing jobs are:

Pharma Regulatory Publishing jobs near you
Infographic showing various Pharma Regulatory Publishing job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 8% Part Time, and 3% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution, with an average salary of $58,981 per year, or $28.4 per hour.

Regulatory Submissions Specialist

New Haven, CT

Celldex Therapeutics
Biotechnology Research and Development • 201 - 500 employees
Learn more about Celldex Therapeuticsexternal

$76K - $99K/yr

Full-time

Medical, Retirement, PTO

Re-posted 4 days ago

Job description

The Regulatory Submissions Specialist is responsible for the paper and electronic compilation and submission of Regulatory submissions and maintaining submission information in the proper RA repositories. The Regulatory Submissions Specialist will assist the regulatory affairs personnel for ensuring all publishing and QC processes are followed and all submission requirements are met prior to dispatching or submitting to the Health Authority.


  • Work with regulatory staff to prepare, assemble, process, format, quality control, publish, submit and archive submissions (e.g., IND, CTA, BLA, Amendments, Supplements, Annual Reports, IMPD and Briefing Documents) to US, CA and other international health authorities using advanced electronic publishing software (eCTD Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions.
  • Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission readiness and compliance
  • Generate regulatory submissions on time and in compliance with Company standards and regional regulatory agency regulations.
  • Assist with troubleshooting system issues
  • Assist with developing best practices in submission publishing and enhancing process efficiency
  • Archive documents according to archiving and document retention regulations

  • A minimum of 1 year of regulatory affairs electronic publishing experience preferred; other relevant experience with clinical trial documentation and electronic systems will be considered.
  • Experience with IND, CTA, BLA submissions
  • eCTD paperless submission experience using agency electronic submission’s gateway (ESG)
  • Experience preparing and submitting regulatory filings using Veeva RIMS
  • Proficient in MS Word formatting large documents and using template
  • EndNotes software experience a plus
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Ability to work in a fast paced environment and to handle multiple tasks
  • Capability to contribute to a team environment
  • Strong communication skills
  • The ability to work independently and as part of a team
  • Knowledge of publishing tools/systems in Pharma industry

The expected base salary for this position is: $76374.00 to $99188.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Apply