Summary/Objective 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.
Essential Functions- 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.
Required Education and Experience- 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.
preferred education and experience- 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.
Position Type/Expected Hours of WorkThis is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 4:30 p.m. Occasional evening and weekend work may be required as job duties demand.
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.
Physical DemandsThe employee is required to sit at a computer for long periods of time. Occasional walking or driving between facilities is needed. This job occasionally requires the need to be able to lift up to ten (10) pounds.
Work EnvironmentThis job operates in a professional office environment and business casual attire. This role may be remote at the discretion of the manager based on current business needs. Occasionally, required in-office work will be needed for remote specialists to meet department needs. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.
