Overview

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.

Responsibilities

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

Qualifications

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

Compensation Statement

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.

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