Regulatory Affairs
Tts Research
Boerne, Tx
Develop and implement strategies for regulatory submission and approvalsManage regulatory teams and provide guidanceReview and change ongoing projects as neededNegotiate with outside agencies as needed to resolve key regulatory issuesPrepare responses to inquires from regulatory authorities.Hire, train, and supervise regulatory staff.Coordinate and prepare document packages for regulatory submissions ensuring compliance with FDAPrepare outlines, summaries, status… Show more Develop and implement strategies for regulatory submission and approvalsManage regulatory teams and provide guidanceReview and change ongoing projects as neededNegotiate with outside agencies as needed to resolve key regulatory issuesPrepare responses to inquires from regulatory authorities.Hire, train, and supervise regulatory staff.Coordinate and prepare document packages for regulatory submissions ensuring compliance with FDAPrepare outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.Coordinate with institutional review boards for regulatory changes, submission and questions Show less