Regulatory Affairs CMC Associate II
$120,000–$140,000 year
Remote · United States
Job Summary
Regulatory Affairs CMC Associate II responsible for planning and managing regulatory submissions across multiple products, including coordination of CMC submissions, preparation/adaptation of eCTD documents for global clinical and commercial submissions, and management of submission trackers. Independently plan routine clinical trial application-related amendments and commercial submissions (e.g., Annual reports, DSUR, health authority queries). Maintains logs and communicates with FDA or other regulatory agencies; collaborates with Vendors/CROs to ensure timely delivery of IND, CTA, EU-CTR submissions; supports regulatory strategy for projects from IND through NDA/BLA and commercialization; ensures high-quality documentation and adherence to regulatory guidelines; prepares presentations for internal/external audiences; remote work enabled.
Required Qualifications
- BS degree required; advanced degree preferred
- Minimum 5 years’ experience in regulatory affairs or a related function in drug/biologic development
- Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus
- Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements
- Familiarity with ICH eCTD structure, knowledge of major market post approval change requirements, and ability to assess impact to CMC content clinical and commercial applications
- Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro
- Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines
- Excellent organizational and planning skills is a requirement
- High level of motivation and proactiveness required to engage in both in-person and remote team members
- Excellent interpersonal, verbal and written communication skills
- Ability to work both independently and collaboratively as part of a team
- Comfortable in a fast-paced small company environment with ability to adjust workload based upon changing priorities
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.