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Regulatory Affairs - Senior (Dossier Development)

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Location Leiden, South Holland Salary competitive
Sector Life Sciences Type contract

Title

Senior Scientist (Regulatory Affairs Specialist) - Dossier Development and Operations
Description:

The Senior Scientist, Dossier Development, VPAD is responsible, with some managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With some managerial guidance, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document, and generation of the Quality module. Assumes personal ownership and accountability for business results and solutions, working with some managerial supervision. Represents the department on multi-functional project development teams to support regulatory filings.

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfil regulatory agency expectations with some managerial guidance. The Senior Scientist supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications with some managerial guidance. Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions with some managerial guidance. Ensures all Quality submissions are completed in a timely manner.

Job Scope/Span of Influence

1. Supports dossier strategy / product development plan creation at a compound level
2. Executes dossier strategy / product development plan with a high level of autonomy
3. Direct responsibility for project budgets
4. May lead dossier authoring activities for late stage projects for regulatory filings with some managerial support
5. Identifies business improvement areas and, under some managerial supervision, drives implementation of improvements
6. Develops process and business improvements within own functional organisation, and aligns with other departments as needed
7. 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.
8. Interfaces mainly internal functional stakeholders, some external stakeholders
9. Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with some guidance
10. Combines technical expertise with management skills. May manage a consultant
11. 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
12. Challenges status quo and has ability to identify innovative approaches to improve products/processes
13. Scope is primarily incremental innovation, within own dept / team.
14. With guidance, resolves cross-functional issues 1
5. 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
16. Works mostly independently on a day to day basis, checks in with supervisor weekly
17. Manages functional or project teams with up to 10 members Education & Experience PhD with Post-doc experience with 3+ years relevant experience OR University degree with 6+ years relevant experience OR Equivalent by experience

IMPORTANT:

Candidates have to have experience and show step-by-step explanation of experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA. 2. Was this Chemicals or Biologics focused? Candidates presented without this detail will not be reviewed

If this position is something that you want to do, and if you believe you have the right qualifications and experience required for the role, please do not hesitate and send us an e-mail with your most recent CV and motivational letter to: j.vanbaalen(@)progressive-nl.com