Role DescriptionYou are responsible 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 of marketing and clinical trial submissions. You coordinate the timeline, virtual document, and generation of the Quality module. You assume personal ownership and accountability for business results and solutions. And you represents the department on multi-functional project development teams to support regulatory filings.
You author/drive sections of the CMC dossier and ensure that final versions comply with regulatory requirements and fulfill regulatory agency expectations. You support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications. You evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions. You ensures all Quality submissions are completed in a timely manner.
Responsibilities- Support dossier strategy / product development plan creation at a compound level - Execute dossier strategy / product development plan with a high level of autonomy - Direct responsibility for project budgets - Lead dossier authoring activities for late stage projects for regulatory filings - Identify business improvement areas and drive implementation of improvements - Develop process and business improvements within own functional organization, and align with other departments as needed - Interface with internal and external stakeholders - Manage complex projects with potentially accelerated priority - Manage functional or project teams with up to 10 members
Requirements- PhD with Post-doc experience with 3+ years of relevant regulatory experience - OR University degree with 6+ years of regulatory experience - Experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA.
Other informationFlexible on location though commitment expected to come to Leiden 1-2 days per week.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hélène de Vries.