Job Details
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager II for a prominent Pharmaceutical client of ours. This position is Remote (EST Hours). Details for the position are as follows:
Job Description:
- Pay: 55.00-65.77/hr on W2. No C2C please.
- 12-month assignment to start with potential for extension or conversion.
- 100 percent remote. Must work EST hours.
- 5 plus years in Regulatory Operations.
- Will work as a liaison between stakeholders and vendors to derive information for the creation and editing of ECTD submissions.
- Acting as a quality control person on ECTD components, they will check the submission(s) for necessary bookmarks and relevant regulatory information as well as coordinate publishing with the vendor.
- They will be responsible for finding errors within the documents and follow up on corrections that need to be made prior to submission for publishing.
- They must know regulations and have insight on what to look for in the ECTD documents.
- Must be knowledgeable with US region regulations regarding ECTD submission.
- Must be able to meet deadlines and oversee deliverables on document submissions. Also, have the insight to find errors and follow up on correction of errors within the document.