Global Regulatory Strategy Lead
3 days ago
Job Title:
Regulatory Affairs Manager CMC
- Key Responsibilities:
- Manage regulatory issues, maintain submission information in relevant systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
- Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
- Author and/or coordinate activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory submissions.
- Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.
- Develop effective relationships with internal partners, i.e., R&D; Quality; Global, Country & Regional Regulatory Leads; other lines.
- Required Skills & Qualifications:
- Mandatory hands-on authoring experience (initial registrations or post-approval variations)
- Sufficient level of knowledge and solid understanding of the development and commercial activities and required to assess technical, scientific and regulatory merits of information, commitments and data to lead teams and/or project(s).
- Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.
Benefits:
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