What are the responsibilities and job description for the Regulatory Affairs Manager II position at The Fountain Group?
Currently I have an opening for a Regulatory Affairs/Systems Manager, Remote, EST. Details for the position are as follows:
Job Description:
Job Description:
- Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
- Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
- Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools, and applications.
- Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
- Performs eCTD submission management across product portfolio to Health Authorities for global development and lifecycle management submissions.
- Oversee outsourced publishing deliverables to ensure successful execution of operational activities for assigned products.
- Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Responsible for electronic submissions and documents meeting regulatory agency and submission standards and technical requirements.
- Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks, and bookmarks, and ensures submissions adhere to local health authority guidelines.
- Competent in the use of electronic document management and submissions publishing tools.
- 3-5 years of experience in regulatory affairs and regulatory systems implementation, UAT testing, and eCTD/CTD submissions.
- 12-month contract with potential for extension/conversion
- Pay: $60-65 hourly rate, depending on experience level
- Remote, EST hours
Salary : $60 - $65
