Senior/Director Regulatory Submissions

Job specification title: Senior/Director Regulatory Submissions

My client are a clinical-stage biotech company listed on NASDAQ with offices in the Netherlands and Cambridge, Massachusetts, US. They are focused on the development of game changing RNA therapies for patients with rare eye diseases. Their Lead Project a phase 3 asset, is currently in need of a highly motivated Senior/Director Regulatory Submissions to provide expertise, detailed planning and oversight for their upcoming NDA/MAA submission.

Location: Netherlands/Remote

For the role of Senior/Director Regulatory Submissions, we are looking for an enthusiastic person to help us with all submission activities and be responsible for the daily activities needed for a successful submission. This role will report directly into the Chief Medical Officer(or designee) and work closely with the Project Leader, Regulatory Affairs and Project Manager.

Responsibilities include:

• Drives the detailed planning/progress/execution of the activities contributing to the Global Submission Plan, through collaborating with team members and/or vendors.
• Will be responsible for the detailed submission planning, support and coordination of all dossiers to be submitted to Health Authorities in order to help Regulatory Affairs deliver a fully comprehensive, reviewable and compliant submission which will support the development and registration of a new product.
• Build and maintain detailed critical path submission plan(s) in MS-Project and ensure team maintains on track for submission deadlines.
• Provides regular updates to Team; assures critical path items are kept up to date and facilitates incorporation in the overarching program plan and provides status update of key submission milestones.
• Ensure that submission issues/risks are identified at an early date and actively contribute to issue resolution before filing dates are impacted, leading facilitation of mitigation and contingency plans.
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
• Demonstrates a good working knowledge of global regulatory practices and requirements and supports CMC, Safety, Clinical, Non-Clinical and other functions as appropriate.
• In depth knowledge of dossier planning/production and provides input into submission requirements, submission strategies, dossier content, and format.