Beschreibung
Areas of responsibility:- Global Submission Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW).
- Accountable for all Publishing, verification, dispatch and management of submission dossiers for all (investigational, marketing authorization, lifecycle management, post approval change management) NVS drug dossiers (e-CTD, NEES, Paper).
- Liaises with a team of Publishers located in EH,SwitzerlandandIndia. Works in a global capacity with colleagues across these regions.
- Provides strategic and operational expertise to teams for routine or maintenance submissions to ensure the timely, quality preparation and execution for electronic and paper submissions to Global Health Authorities (EMA, FDA, Swiss Medic, LATAM, ROW)
- Supports implementation of Technical Format requirements and collaborates with DRA Operations Submission Standards and Strategy team members to develop a company business guidance on publishing deliverables.
- Partner with LF (Clinical, Preclinical, Research and Technical) Coordinators to negotiate every submission component target date with the goal of achieving the target submission date for minor submissions.
- Reports and updates Franchise Head for Submission Publishing on submission progress. Provide monthly report to FH-GSP, and line management within DRA Ops.
- Represents DRA Ops on cross-functional project teams (non- submission related activities).
- Participates in other department activities / initiatives as required
Ideal Background
- 5-8 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia,Latin America, etc).
- BS or MS or with comparable relevant experience and demonstrated capability.
- Fluency in English as a business language. Additional language is an asset.
- Expert in HA submission publishing requirements globally.
- Strong knowledge, of Regulatory Business processes and related tools
- Team management experience with cross functional responsibilities.
- High level of organizational awareness.
More Details:
- 6 Months fulltime
- Location: North Switzerland
- Start date: a.s.a.p
Please notice: European citizens are preferred
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real, please visit www.realstaffing.com