Senior Regulatory Affairs Lead: eCTD Submissions & Compliance

Avion Pharmaceuticals, LLC; Alpharetta (GA); Remote; USD 90,000 - 140,000; Full time

Job summary

Avion Pharmaceuticals, LLC is seeking a Senior Regulatory Affairs Associate to lead eCTD submissions, coordinate with clients and regulatory agencies, and assess regulatory impact of changes.

The role includes training junior staff on compliant submissions, reviewing colleagues' work for accuracy, and ensuring timely delivery of applications, supplements, and annual reports in a fast-paced environment.

Qualifications

• Prepare and maintain eCTD submissions and lifecycle.
• Review the work of other Regulatory staff for content, format, and validation.
• Coordinate with other departments to meet submission deadlines.
• Provide regulatory advice and documentation to clients in a timely manner.

Responsibilities

• Gather documentation, draft, and prepare eCTD-compliant submissions.
• Review colleagues' submissions for content, format and validation.
• Proactively work with other departments to provide information for submissions.
• Proactively work with clients to ensure a successful working relationship by providing information and regulatory guidance.
• Revise labeling as requested by FDA or partners.
• Edit, validate, and eList a drug product SPL as needed.
• Participate in audits by federal, state, and local agencies as needed.
• Train on new regulations via governmental agency webinars.
• Review regulatory guidance to ensure continuing compliance.
• Represent the department at interdepartmental and agency meetings.
• Participate in compliance activities.

Skills

Regulatory affairs

eCTD submissions

Document management

FDA interactions

Training & mentoring

Education

Bachelor's degree in chemistry

Tools

CDERDirect

Electronic Submissions Gateway

SPL Xforms

Job description

Avion Pharmaceuticals, LLC is seeking a Senior Regulatory Affairs Associate to lead eCTD submissions, coordinate with clients and regulatory agencies, and assess regulatory impact of changes.

The role includes training junior staff on compliant submissions, reviewing colleagues' work for accuracy, and ensuring timely delivery of applications, supplements, and annual reports in a fast-paced environment.