Regulatory Affairs Associate, Publishing in at Delcath Systems Inc

POSITION SUMMARY

The Regulatory Affairs Associate is responsible for formatting submission documents using various applications as well as publishing, eCTD compilation, and review and dispatch of regulatory submissions. To support our team’s ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has requisite knowledge of ICH guidelines and eCTD submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Independently perform document formatting on MS word documents and publish PDFs to comply with FDA and other health authority specifications, eCTD compilation for submission, including troubleshooting issues and identifying solutions.

Assist in the preparation of regulatory applications to achieve departmental and organizational objectives.

Assist the lead publisher by preparing supportive documentation like content plans and timelines for regulatory submissions and independently publish assigned eCTD XML submissions using publishing software.

Facilitate and coordinate assembly of documents for regulatory submissions, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements

Maintain publishing and quality control logs and records for submissions, documents, and archiving.

Provides technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.

Ensures that documents created for e-Publishing are correct and appropriate and according to standards, utilizing Word and Adobe for document processing/formatting, and to edit, proof, and create bookmarks and hyperlinks according to guidance and processes.

Perform quality checks on regulatory documents and submissions to ensure accuracy, consistency, and compliance with regulatory requirements and company standards.

Identify opportunities for process optimization and efficiency enhancement within the regulatory submission process, contributing to the continuous improvement of internal workflows and systems.

Provide general support to regulatory team by taking meeting minutes, conducting literature searches using numerous databases to obtain appropriate literature for study progress, other special projects and miscellaneous duties as needed.

SUPERVISORY RESPONSIBILITIES

This position has no direct reports.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree or an equivalent combination of education and a minimum of 1-2 years of experience in regulatory affairs or related roles within the life sciences industry.

Minimum of 1 year experience building XMLs for eCTD submissions, preferably in Lorenz docuBridge.

Strong technical systems skills (i.e. Adobe Acrobat Pro, XML and Microsoft Office 365 including SharePoint, Power Point and Excel).

Have a good knowledge of ICH guidelines and CTD experience assisting in publishing major and minor (NDA, IND and life-cycle management submission) submissions is preferred.

Experience managing content in SharePoint, Microsoft Teams and Shared drives.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in a timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.