Regulatory Affairs Associate Jobs

Job Title: Publishers (US Submissions)

Location: Deerfield IL Or 100% Remote

Duration: 12 Month

Pay Range: $25.00/hr to $30.00/hr on W2

:

• This position is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements

• Serves system administrator for the client's US Regulatory electronic document management system

• He/she will serve as the primary publisher of US Regulatory submissions (Drug and Device)

• Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time

• Works with the Manager and document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements

• Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types

• Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System

Skills Required:

We are looking for someone with submission experience with FDA, someone who can support Drug/Device submissions using eCTDXpress and document management tools (like RIM).