Senior Regulatory Publisher
Company: Katalyst Healthcares & Life Sciences
Posted on: April 8, 2021
- Katalyst Healthcares & Life Sciences is hiring entry level
candidates for several positions for contract research in Clinical
trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug
Safety and Pharmacovigilance and Clinical Research field. We work
with University hospitals, pharmaceutical companies and recruiting
partners. Job Description Job Description
- The Contract Regulatory Publisher's primary role is to provide
document and sequence level publishing and compilation for US, EMA
and RoW regulatory submissions.
- This role also provides support for the planning, acquisition,
preparation, compilation, quality control (QC), retention and
submission of regulatory documents to US and ex-US health
authorities. He/she ensures that documentation and submissions are
complete and are in compliance with relevant health authority
requirements (e.g., Food and Drug Administration (FDA), European
Medicines Agency (EMA), company Standard Operating Procedures
(SOPs), and other directives to allow for initiation of clinical
trials and subsequent marketing authorizations. He/she maintains
regulatory submissions, health authority correspondence, and
relevant documentation in an appropriate archive location in
accordance with regulatory guidelines and internal company
standards, including management of files in an Electronic Document
Management System (eDMS) system.
- He/she works cross-functionally with internal departments and
external resources on Regulatory Affairs related issues.
- The Contract Regulatory Publisher supports adherence to
relevant regulatory requirements and company SOPs as
- This is a long term consulting opportunity Primary duties and
- Gathers, prepares (as needed) and assembles the essential
documents from internal teams and/or external Clinical Research
Organizations (CROs) required for US and global regulatory
submissions; confirms the accuracy and quality of submission
content, obtains required approvals and ensures that the documents
are submitted in accordance with external regulatory and internal
- Publishes electronic submissions in Electronic Common Technical
Document (eCTD), or non-eCTD format, for FDA, EMA and other
regulatory agencies. This may include source document formatting,
internal hyperlinking and bookmarks and sequence level publishing.
This may also include interacting with third party publishing
vendors to ensure submission timelines are met. The range of
submission types includes, but is not limited to, Investigational
New Drug applications (INDs)/Clinical Trial Applications (CTAs),
Protocol Amendments, Safety Reports, Chemistry, Manufacturing and
Control (CMC) Amendments, New Drug Applications (NDAs), Variations,
Health Authority Meeting Briefing Packages, Labelling, and
Responses to Agency Queries.
- Creates and facilitates regulatory document- and
submission-related eDMS workflows maintaining communication with
participating panelists as needed.
- Monitors progression of workflows providing copies of
documentation to colleagues/contractors on request.
- Maintains and tracks regulatory submission documentation (hard
copy or electronic), including regulatory authority correspondence,
in an appropriate document management system or hardcopy archive
location to ensure regulatory compliance and in accordance with
company document standards.
- May act as a liaison with external, third-party organizations
to provide regulatory support for the completion of outsourced
regulatory submissions. Minimum level of education and work
- High School diploma and a minimum of 3 years of relevant
Regulatory Affairs eCTD publishing experience in a pharmaceutical,
biotechnology, CRO or related environment. Special knowledge or
- Demonstrated, hands-on experience preparing regulatory
submissions in eCTD format (both US and ex-US).
- Experience with eCTDXPress electronic publishing software
(document and sequence level publishing).
- Experience with, and the ability to work within, an eDMS
- Current knowledge of global regulatory standards, registration
requirements and approval.
- Knowledge of European regulatory requirements.
- Proficiency with use of ISI Toolbox.
- Understanding of the Quality Assurance (QA) function as it
applies to regulatory documents including the ability to review and
*QC documents intended for regulatory submissions.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required,
in a fast-paced, matrixed, team environment consisting of internal
and external team members.
- Analytical thinker with excellent problem solving skills and
the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills
including the ability to support, manage and prioritize multiple
projects. Special knowledge of skills preferred
- Bachelor's degree in a related discipline. Additional
Information All your information will be kept confidential
according to EEO guidelines. Other jobs at Katalyst Healthcares &
Keywords: Katalyst Healthcares & Life Sciences, Trenton , Senior Regulatory Publisher, Other , Bridgewater, New Jersey
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