Sr. Regulatory Affairs Associate
HybridAlpharetta, Georgia, United States
Job Summary
Prepare eCTD-compliant submissions, including applications, supplements, and annual reports, based on client needs. Independently gather documentation, draft content, and validate work for format and accuracy. Proactively coordinate with internal departments and clients to meet submission deadlines and provide regulatory advice. Revise labeling to conform to FDA requirements and changes to the Reference Labeling Directory. Edit, validate, and eList drug product SPLs as needed. Participate in audits with federal, state, and local agencies and represent the department at interdepartmental meetings. Actively train on new regulations and governmental agency webinars to maintain compliance knowledge. This full-time role operates Monday through Friday, 8:00 a.m. to 4:30 p., with occasional evening or weekend work. Travel is primarily local, though out-of-area trips may occur. The position involves remote work at the manager's discretion.
Required Qualifications
- Bachelor's degree in chemistry or life sciences
- 5-7 years of applicable experience
- Working understanding of basic office applications (Word, Excel, Acrobat)
- Preparation and maintenance of eCTD submissions and lifecycle
- Occasional evening and weekend work
- Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected
- Ability to sit at a computer for long periods of time
- Occasional walking or driving between facilities
- Ability to lift up to ten (10) pounds
- Business casual attire
- This role may be remote at the discretion of the manager based on current business needs
- Occasionally, required in-office work
Desired Qualifications
- Working knowledge of CDERDirect, Electronic Submissions Gateway, and SPL Xforms
- Familiarity with eCTD publishing and electronic document management systems
- RAC certification
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