Regulatory Operations Specialist
Proclinical is currently seeking a Regulatory Operations Specialist for a pharmaceutical company located in Plainsboro, NJ. Successful candidate's primary function will be to support the global extent of e-submissions and use of internal systems for regulatory submissions.
- Independently troubleshoot technical publishing issues .
- Participation within industry meetings to increase presence in the field of e-submission.
- Perform final quality check of electronic and paper versions of regulatory submissions.
- Processes electronic files incorporating bookmarks, links and other formatting requirements and transmits these for filings and related regulatory notifications in accordance with established timeframes.
- Responsible for the management, publishing and submission of Electronic Common Technical Document (eCTD) submissions, including major filings Technology support.
- Thoroughly knowledgeable of governmental regulatory requirements regarding document printing, publishing and transmission.
- Oversee tracking, coordinating, publishing, and submitting of all product submissions.
- Use Insight Manager and Ezsubs where necessary to support eCTD submissions.
- Work in direct relation with TA to coordinate submission timelines.
Skills and Requirements:
- Bachelor's Degree or equivalent experience required, 5+ years of experience within the regulatory environment, with a concentration in document management and eCTD publishing.
- Preferred Training certification on Ezsubs, Documentum (First Consulting Group (FCG) First Docs), ISI toolbox.
- Previous hands on experience with the eCTD processes behind the compilation of Investigational New Drugs (INDs)/ New drug application (NDAs)/Amend/Supplements.
- Specific or technical job skills: Thorough understanding of the eCTD structure as well as FDA and International Conference on Harmonisation (ICH) specifications for eCTD submissions.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amanda Rivera at (+1) 267-435-8555 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.