In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the organization.
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- Supports dossier strategy / product development plan creation at a compound level - Executes dossier strategy / product development plan with a high level of autonomy - Direct responsibility for project budgets - May lead dossier authoring activities for late stage projects for regulatory filings with some managerial support - Identifies business improvement areas and, under some managerial supervision, drives implementation of improvements - Develops process and business improvements within own functional organization, and aligns with other departments as needed - With some guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA. - Interfaces mainly internal functional stakeholders, some external stakeholders - Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with some guidance
- Combines technical expertise with management skills. May manage a consultant - Manages limited number of projects with standard, rather than accelerated priority, or with assistance of a Senior staff member, manages complex projects with potentially accelerated priority - Challenges status quo and has ability to identify innovative approaches to improve products/processes - Scope is primarily incremental innovation, within own dept / team. - With guidance, resolves cross-functional issues - Appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support. With some guidance, takes day- to-day decisions on operational priorities for his/her team, and allocates resources accordingly - Works mostly independently on a day to day basis, checks in with supervisor weekly - Manages 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 - Regulatory background - Experience with late stage development - Experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA - Fluent English
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.