Senior Regulatory Submission Lead
$120 - $175/hr
Support eCTD publishing activities and FDA-facing submission needs. Identify gaps, track ... Hourly Rate: $120-$175/hour.
$120 - $175/hr
Support eCTD publishing activities and FDA-facing submission needs. Identify gaps, track ... Hourly Rate: $120-$175/hour.
$120 - $175/hr
Support eCTD publishing activities and FDA-facing submission needs. Identify gaps, track ... Hourly Rate: $120-$175/hour.
Almont, CO · On-site
$65 - $75/hr
Ability to provide secondary publishing support for eCTD submissions when required. * Ability to ... The pay range provided in this posting reflects a W2 hourly rate; other employment options may be ...
Almont, CO · On-site
$65 - $75/hr
Ability to provide secondary publishing support for eCTD submissions when required. * Ability to ... The pay range provided in this posting reflects a W2 hourly rate; other employment options may be ...
... handoff to publishing) and contribute to departmental trackers and integrated timelines ... Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD ...
... handoff to publishing) and contribute to departmental trackers and integrated timelines ... Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD ...
Lexington, MA · On-site +1
$206K - $227K/yr
Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation ... hourly rate or base annual full-time salary for all positions in the job grade within which this ...
Lexington, MA · On-site +1
$206K - $227K/yr
Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation ... hourly rate or base annual full-time salary for all positions in the job grade within which this ...
... handoff to publishing) and contribute to departmental trackers and integrated timelines ... Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD ...
... handoff to publishing) and contribute to departmental trackers and integrated timelines ... Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD ...
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
Summit, NJ · On-site
$50.23/hr
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
Summit, NJ · On-site
$50.23/hr
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
Summit, NJ · On-site
$50.23/hr
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
Summit, NJ · On-site
$50.23/hr
... management, publishing, and coordination of Electronic Common Tech Document (eCTD) modules ... The hourly base pay range for this position is below. The specific rate will depend on the ...
$31.50 - $40.41/hr
Working knowledge of Adobe Acrobat for document editing, formatting, and publishing. * Team ... Experience with writing global regulatory applications in eCTD format What is expected of you and ...
$31.50 - $40.41/hr
Working knowledge of Adobe Acrobat for document editing, formatting, and publishing. * Team ... Experience with writing global regulatory applications in eCTD format What is expected of you and ...
$110 - $185/hr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$110 - $185/hr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$139K - $184K/yr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$139K - $184K/yr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$103K - $138K/yr
... with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$103K - $138K/yr
... with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$139K - $184K/yr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$139K - $184K/yr
Experience with CTD/eCTD * Experience with publishing documents in Adobe Acrobat Professional ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$103K - $138K/yr
... with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$103K - $138K/yr
... with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working ... Please note that the listed range reflects the base salary or hourly range only. Non-Commercial ...
$12.74 - $17.31
8% of jobs
$17.31 - $21.88
10% of jobs
$22.58 is the 25th percentile. Wages below this are outliers.
$21.88 - $26.44
51% of jobs
$29.87 is the 75th percentile. Wages above this are outliers.
$26.44 - $31.01
10% of jobs
$31.01 - $35.58
9% of jobs
$35.58 - $40.14
4% of jobs
$40.14 - $44.71
3% of jobs
$44.71 - $49.28
1% of jobs
$49.28 - $53.85
2% of jobs
$53.85 - $58.41
2% of jobs
$58.41 - $62.98
1% of jobs
$12
$29
$62
Cities with the most Hourly Ectd Publisher job openings:
The most popular types of Ectd Publisher jobs are:
States with the most job openings for Hourly Ectd Publisher jobs include:
$120 - $175/hr
Full-time
Re-posted 9 days ago
Job Description Contact: Alexandra Spink - aspink@penfieldsearch.com No 3rd party candidates Location: Bay Area-based role Work Model: 5 days onsite per week We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on submission execution and cross-functional coordination to ensure regulatory content is aligned, complete, and ready for filing. Key Responsibilities Coordinate BLA submission activities across Module 2 and Module 5, including timelines, deliverables, and submission readiness
Support preparation and review of submission content, including CSRs, appendices, ISS, ISE, and related regulatory documentation. Ensure clinical and biometrics outputs are incorporated into accurate, regulatory-ready submission content. Manage submission documentation, QC, version control, and workflows within Veeva Vault.
Support eCTD publishing activities and FDA-facing submission needs. Identify gaps, track dependencies, and help maintain submission timelines. Qualifications 7+ years of experience supporting regulatory submissions within the life sciences industry.
Advanced scientific or clinical training preferred (PhD, PharmD, or MD), with prior ophthalmology experience strongly preferred. Hands-on BLA submission experience with strong knowledge of FDA Module 2 and Module 5 requirements. Experience independently coordinating submission activities from planning through filing, including FDA interactions and regulatory communications.
Hands-on experience using Veeva Vault to support regulatory submissions, including document management, workflows, QC, and submission readiness, with a strong understanding of eCTD processes and publishing activities. Success in This Role The successful candidate will quickly step into an active BLA submission environment, coordinate across functions, and help ensure Module 2 and Module 5 deliverables remain aligned and submission-ready through filing. Hourly Rate: $120-$175/hour.
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Recruiting and staffing services
11 - 50 Employees
Fairfield, CT, US
2012