Job Description

Job Responsibilities:

• Acts as the primary point of contact for regulatory functions as appropriate in the product’s lifecycle.
• The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
• Ensure hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
• Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.
• Responsible for electronic submissions and documents meeting regulatory agency and Biogen submission standards and technical requirements.
• Quality checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
• Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
• Competent in the use of electronic document management and submissions publishing tools

Skills:

• eCTD Submission Management
• Publishing
• QC checks
• Health Authority Guidelines/Regulations

Education/Experience:

• Minimum Education qualification required. : ; Bachelor's
• Years of experience required: 5 plus years of experience

Job Tags

Similar Jobs