What are the responsibilities and job description for the Regulatory Affairs Manager position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Join a leading biopharma company supporting critical regulatory systems initiatives.
- We're seeking a detail-oriented consultant with expertise in Regulatory Systems, eCTD submission management, and experience working with global IT and cross-functional 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 Biogen'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 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 end-user training.
- Solid understanding of HA regulations related to submissions and regulatory technologies.
- Education: No Degree Required.
- 3-5 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 technology-related Health authority guidelines/regulations.
- LI-AT1.
- Skills: GCP (Good Clinical Practice), Regulatory Affairs Operations.
- Regulatory Briefing Documents, Submissions.
