White Plains, NY · On-site
$80K - $110K/yr
Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments ...
White Plains, NY · On-site
$80K - $110K/yr
Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments ...
... Publisher, eCTDXpress etc) 5+ yrs of IT experience and 4+ relevant years of experience in Regulatory publishing technologies Strong knowledge in Publishing technologies and Labelling systems (ALiCE ...
... Publisher, eCTDXpress etc) 5+ yrs of IT experience and 4+ relevant years of experience in Regulatory publishing technologies Strong knowledge in Publishing technologies and Labelling systems (ALiCE ...
... Publisher, eCTDXpress etc) * 5+ yrs of IT experience and 4+ relevant years of experience in Regulatory publishing technologies * Strong knowledge in Publishing technologies and Labelling systems ...
... Publisher, eCTDXpress etc) * 5+ yrs of IT experience and 4+ relevant years of experience in Regulatory publishing technologies * Strong knowledge in Publishing technologies and Labelling systems ...
The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a ...
The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a ...
Working in close collaboration with the Head of Global Submission Publishing and Global Submission ... Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of ...
Working in close collaboration with the Head of Global Submission Publishing and Global Submission ... Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of ...
Regulatory Strategy, Regulatory Publishing, and cross-functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements. The role assumes end-to ...
Regulatory Strategy, Regulatory Publishing, and cross-functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements. The role assumes end-to ...
Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health ...
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Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health ...
Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health ...
Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health ...
Director and Publisher, University of Hawaii Press Position Number: 0089091 Hiring Unit: Office of ... Ability to work within the regulations or a public institution and a unionized environment.
Director and Publisher, University of Hawaii Press Position Number: 0089091 Hiring Unit: Office of ... Ability to work within the regulations or a public institution and a unionized environment.
Pleasanton, CA · On-site
$86K - $102K/yr
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
Pleasanton, CA · On-site
$86K - $102K/yr
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
$86K - $102K/yr
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
$86K - $102K/yr
Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities ...
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
Austin, TX · On-site +1
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
Austin, TX · On-site +1
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
Bethesda, MD · Hybrid
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic ...
Bethesda, MD · Hybrid
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic ...
Manhattan, NY · On-site +1
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
Manhattan, NY · On-site +1
$54K - $58K/yr
Employment is subject to New York State tax withholding under applicable regulations. Macmillan Publishers is the U.S. trade company that is part of the Holtzbrinck Publishing Group, a large family ...
The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a ...
The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a ...
Bethesda, MD · On-site
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic ...
Bethesda, MD · On-site
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic ...
Signal Hill, CA · On-site
Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The ... Maintain open, timely and effective communications with all publishing contributors and responsible ...
Quick apply
Signal Hill, CA · On-site
Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The ... Maintain open, timely and effective communications with all publishing contributors and responsible ...
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
Regulatory Publishers often encounter tight deadlines and frequently changing regulatory requirements, which can make prioritizing tasks and staying up-to-date a challenge. Managing complex submissions that involve compiling, formatting, and validating large volumes of documentation requires both technical and organizational expertise. Additionally, close collaboration with regulatory affairs, medical writers, and quality assurance teams is essential to ensure submissions are accurate and compliant. Overcoming these challenges involves a keen attention to detail, adaptability, and strong communication skills, all of which are highly valued in this role.
A Regulatory Publisher is responsible for compiling, formatting, and submitting regulatory documents to health authorities, ensuring compliance with global submission standards such as eCTD (Electronic Common Technical Document). They work closely with regulatory affairs teams to prepare dossiers for drug approvals, variations, and renewals. Their role involves quality control, document troubleshooting, and staying up to date with regulatory submission requirements. Effective use of publishing software and strict adherence to guidelines are essential for ensuring successful submissions.
To thrive as a Regulatory Publisher, you need a thorough understanding of regulatory submission requirements, document management, and attention to detail, typically supported by experience in the pharmaceutical or biotechnology industries. Proficiency with electronic submission tools such as eCTD publishing software (e.g., Lorenz DocuBridge, Extedo), and familiarity with FDA or EMA guidelines, are highly valued. Strong organization, effective communication, and the ability to manage multiple projects simultaneously are important soft skills. These abilities are vital for ensuring timely, compliant submissions and efficient collaboration across regulatory and project teams.
$80K - $110K/yr
Full-time
Posted 14 days ago
