Role DescriptionYou are for developing the technical eCTD sections to support Regulatory CMC dossier applications. You coordinate and provide technical oversight for the generation of the CMC dossier for marketing and clinical trial submissions. You coordinates the timeline, virtual document, and generation of the Quality module. You assume personal ownership and accountability for business results and solutions and you represent the department on multi-functional project development teams to support regulatory filings.
You author sections of the CMC dossier and ensure that final versions comply with regulatory requirements, and you fulfill regulatory agency expectations. You support technical specialists in the development of responses to health authority inquiries, regarding clinical trials and marketing applications. You evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions. You ensure all Quality submissions are completed in a timely manner.
Responsibilities1. Supports dossier strategy / product development plan creation at a compound level 2. Executes dossier strategy / product development plans with a high level of autonomy 3. Direct responsibility for project budgets 4. Leads dossier authoring activities for late stage projects for regulatory filings 5. Identifies business improvement areas and drives implementation of improvements 6. Develops process and business improvements within own organization 7. Interfaces with internal and external stakeholders 8. Manages projects with both standard and accelerated priority 9. Resolves cross-functional issues 10. Appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support. Takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly 11. Works mostly independently on a day to day basis, checks in with supervisor weekly 12. Manages functional or project teams with up to 10 members
Requirements- PhD with Post-doc experience and 3+ years of industry experience - OR University degree with 6+ years industry experience - Experience with Module 3 Dossier Development for premarketing IND/IMPD or MAA/BLA
Other informationFull time preferred, 32 hours discussable. For Expert candidates, 20 hours is also discussable. Flexible on location, though you are expected to come to Leiden 1-2 days per week. This a long-term position.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.