Sr. Regulatory Affairs Associate

Avion Pharmaceuticals•Alpharetta, GA

14d•Hybrid

About The Position

The Senior Regulatory Affairs Associate is responsible for preparing submissions in eCTD format, actively participating in client meetings, interacting with the various governmental agencies when needed, and assessing change control for regulatory impact. In addition, the Associate will aid in the development and training of other associates in creating compliant submissions and understanding the impact of regulation changes.

Requirements

Bachelor’s degree in chemistry or life sciences, or 5-7 years of applicable experience.
Working understanding of basic office applications (Word, Excel, Acrobat).
Preparation and maintenance of eCTD submissions and lifecycle.

Nice To Haves

Working knowledge of CDERDirect, Electronic Submissions Gateway, and SPL Xforms.
Familiarity with eCTD publishing and electronic document management systems.
RAC certification a plus, but not mandatory.

Responsibilities

Independently gather documentation, draft, and prepare eCTD-compliant submissions (applications, supplements, and annual reports) 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.