Rho is seeking an experienced regulatory document manager proficient in electronic publishing and submission to FDA and other regulatory authorities. Experience with other document preparation and regulatory operations activities such as regulatory review of site essential documents or editorial quality review in general is also preferred.
Publishes regulatory documents in accordance with eCTD standards and regulatory agency specifications.
Reviews essential regulatory documents according to Rho SOPs and sponsor specifications, ensuring accuracy and completeness
Minimum of five (5) years’ experience in regulatory document and submission assembly and preparation, ideally in the electronic document publishing context.