Senior Regulatory Affairs: eCTD Submissions (Remote)

Avion Pharmaceuticals, LLC; Alpharetta (GA); Hybrid; USD 100,000 - 150,000; Full time

Job summary

Avion Pharmaceuticals, LLC in Alpharetta, GA is seeking a Senior Regulatory Affairs Associate responsible for preparing eCTD submissions, coordinating with client teams, and assessing regulatory impact of changes. You will ensure timely, compliant submissions and maintain regulatory knowledge.

You will revise labeling per FDA requests, prepare SPLs, participate in audits, and train junior staff on new regulations. Travel is primarily local; some remote work may be allowed based on business needs.

Qualifications

• BS in chemistry or life sciences or 5-7 years relevant experience.
• Working understanding of basic office applications (Word, Excel, Acrobat).
• Preparation and maintenance of eCTD submissions and lifecycle.

Responsibilities

• Independently gather documentation, draft, and prepare eCTD-compliant submissions based on client needs.
• Review the work of other Regulatory staff for content, format, and validation.
• Proactively work with other departments to provide information and suitable documentation for clients to meet submission deadlines.
• Proactively work with clients to ensure a successful working relationship by providing information, documentation, and regulatory advice in a timely manner.
• Revise labeling as requested by the FDA, internal and external partners, or to conform to changes to the RLD.
• Edit, validate, and eList a drug product SPL as needed.
• Participate in audits by federal, state, and local Agencies as needed.
• Actively train on new regulations and in governmental agency webinars to increase regulatory knowledge and readiness
• Review federal, state, and local regulatory guidance and revisions to ensure continuing compliance.
• Represent the department at interdepartmental meetings and governmental agency meetings.
• Participate in compliance activities as required.

Skills

Regulatory affairs

eCTD submissions

FDA/agency liaison

Documentation

Audits

Regulatory analysis

Training

Education

Bachelor's degree in chemistry or life sciences

RAC certification

Tools

CDERDirect

Electronic Submissions Gateway

SPL Xforms

Job description

Avion Pharmaceuticals, LLC in Alpharetta, GA is seeking a Senior Regulatory Affairs Associate responsible for preparing eCTD submissions, coordinating with client teams, and assessing regulatory impact of changes. You will ensure timely, compliant submissions and maintain regulatory knowledge.

You will revise labeling per FDA requests, prepare SPLs, participate in audits, and train junior staff on new regulations. Travel is primarily local; some remote work may be allowed based on business needs.