Regulatory Affairs Manager II

Job Description

Duties and Responsibilities:

• Performs eCTD submission management across client’s 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 client 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.

Experience:

• 3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.
• Should have Regulatory Submission & eCTD publishing experience.

Skills:

• 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.