Regulatory Affairs Manager
Regulatory Affairs Manager
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Salary Not Disclosed
1 Vacancy
Job Description
- Join a leading biopharma company supporting critical regulatory systems initiatives.
- Were seeking a detailoriented consultant with expertise in Regulatory Systems eCTD submission management and experience working with global IT and crossfunctional teams to drive system implementation and Quality Control Process Documentation & Testing.
- Key Focus Areas: Regulatory Systems Expertise eCTD Submission Management Global Collaboration with IT & Regulatory Stakeholders Quality Control Processes Documentation & Testing.
- Performs eCTD submission management across Biogens product portfolio to Health Authorities for global development and lifecycle management submissions.
- Oversee outsourced publishing deliverables to ensure successful 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 company 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.
- Regulatory Operations & Regulatory Systems & submission process experience.
- Strong tool knowledge: Veeva InSight Docubridge CARA etc.
- Process documentation SOPs SOWs workflow mapping UAT testing.
- Experience supporting system implementation and enduser training.
- Solid understanding of HA regulations related to submissions and regulatory technologies.
- Education: No Degree Required.
- 35 years of experience in regulatory operations with experience in Regulatory systems and submissions.
- Regulatory Systems experience (i.e. 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 technologyrelated Health authority guidelines/regulations.
- LIAT1.
- Skills: GCP (Good Clinical Practice) Regulatory Affairs Operations.
- Regulatory Briefing Documents Submissions.
Employment Type
Full Time
