Meitheal Pharmaceuticals, Inc. · 1 week ago
Senior Associate Regulatory Affairs -Publishing
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$70K/yr - $85K/yr
3+ years expMeitheal Pharmaceuticals, Inc. is focused on the development and commercialization of generic injectable medications. The Regulatory Affairs Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs, ensuring compliance with FDA regulations and preparing high-quality submission dossiers.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications
Manage pre-approval, post-approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE-0, CBE-30, Amendments, Supplements, and Safety Reports
Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements
Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports
Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead
Handle ANDA, NDA, and BLA submissions for pre-approval, post-approval, and promotional materials, supporting full product lifecycle management
Develop and maintain an in-depth understanding of relevant US and EU regulatory requirements for submissions
Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance
Perform administrative tasks related to submissions, including transferring files via FTP servers
Input submission information into internal databases and systems per company procedures
Perform other duties as assigned to support Regulatory Affairs publishing operations
Qualification
Required
Bachelor's degree from a 4-year college or university
Over 3-4 years pharma experience and/or training
Ability to prioritize and multitask
Organized and detailed orientated
Have a sense of urgency to meet all required deadlines
Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc)
Company
Meitheal Pharmaceuticals, Inc.
Founded in 2017, Meitheal Pharmaceuticals is a privately owned pharmaceutical company focusing on generic injectable products.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$35MKey Investors
JP Morgan
2023-08-22Debt Financing· $35M
Leadership Team
T
Tom Shea
Chief Executive Officer
Keith Robinson
Chief Medical Officer
Recent News
Business Wire
2025-10-21
Company data provided by crunchbase