Description Manager, Regulatory Submission Management Regulatory Submission Management (RSM) acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized.
We are a trusted companion across Regulatory Affairs (RA), bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together.
This role is focused on submission planning and execution.
You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to and manage global submission content plans, and lead review and planning processes for multiple products or projects.
You will represent RSM on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on regulatory submissions requirements and timing.
You may also represent RSM on other cross-functional initiatives.
You will plan and have oversight for assigned deliverables and may serve as an RSM lead for regulatory submissions.
You will participate in identifying and developing process improvements, new standards, and updating systems in support of submissions.
You may coach, train, and provide guidance to less experienced RSM colleagues.
Essential Duties and Job Functions: Manages the submission execution activities for a wide variety of global submission projects, such as clinical study reports (CSRs), variations, investigator's brochures, DSURs, regulatory responses, original INDs and amendments.
May support regulatory portfolio planning activities or submission execution for multiple submissions of varying complexity including global marketing applications.
Represents RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for technical strategies to achieve fast frictionless filings or meet technical health authority requirements; may act as a technical and operational lead for submission execution.
Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.
Supports the planning and preparation of maintenance activities for early development and late-stage regulatory deliverables with direction from RA Liaisons.
Organizes preparation of high-quality documents for submissions such as cover letters, forms and other documents as assigned.
Participates in development/improvement of submission standards, submission templates, and validation decision trees.
May also participate in other special projects and/or represent RSM in other cross-functional initiatives.
Where applicable, oversees the work of external contractors supporting deliverables and other activities.
Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables.
May coach, train, and provide guidance to less experienced RSM colleagues.
Ensures work complies with established practices, policies, and processes, and any regulatory or other requirements.
Education