Regulatory Affairs Specialist
Hours per week: 40 preferred, 32 hours discussable
Location: Leiden, Flexible on location though commitment expected to come to Leiden 1-2 days per week.
The selected contractor 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.
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 organization, 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
Experience / education
* PhD with Post-doc experience with 3+ year's relevant experience
OR University degree with 6+ year's relevant experience OR Equivalent by experience
* Regulatory background
* Experience with late stage development
Are you the new Regulatory Affairs Specialist? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com