(Senior) Director Regulatory Operations - NDA/MAA SubmissionsApply for (Senior) Director Regulatory Operations - NDA/MAA Submissions . Opens in new window.
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
For our Lead Project, Sepofarsen, a phase 3 asset, ProQR is currently in need of a highly motivated (Senior) Director Regulatory Operations - NDA/MAA Submissions to provide expertise, detailed planning and oversight for our upcoming NDA/MAA submission.
Location: Leiden, NL ideally. Virtual working would be an option for the right candidate.
For the role of Senior Director NDA/MAA 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 will work closely with the Project Leader, Regulatory Affairs and Project Manager.
- 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.
- Minimum of a Bachelor’s (Master’s Degree preferred), preferably in a health-related field
- 5 years of proven experience as a Regulatory/Submission Specialist or Senior Project Manager in the pharmaceutical/biotech industry with demonstrated knowledge of project management tools in general and MS Project in specific
- Experience with (expedited/rolling) MAA/NDA submissions in EU and US
- Sound eCTD knowledge
- Experience with orphan diseases and accompanying designations (ODD, fast track, PRIME, rare pediatric disease) an advantage
- Demonstrated ability to effectively manage scope, resources and time of assigned submission project
- Be an expert in planning and tracking; detailed focus with a close eye on the big picture
- Understand financial aspects, including knowledge of resource planning (resources and budget)
- Demonstrated ability to build relationships at all levels within the organization and to influence, negotiate and drive organizational engagement
- Have a good understanding of drug development processes and regulations (GLP/GMP/GCP).
Skills and competencies that are required for making the difference:
- Outstanding project management and planning skills
- Excellent communication skills
- Pro-active and “can-do” attitude
- Flexible and resilient to change
- Reliable Team player
- Excellent knowledge of spoken and written English
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock option
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please contact Laura Faber via email@example.com in case you have any questions.