Marketing Authorisation Regulatory Affairs Manager

Canton of Basel-Stadt  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Regulatory Affairs Manager - 9 month contract

My client an orphan drug company based in Basel, Switzerland is currently searching for a Regulatory Affairs Manager to be responsible for the operational and strategic activities in drug development, centralised procedure for pre and post-marketing phases.

The role reports to the Head Drug Regulatory Affairs and will collaborate closely with

other functions such as Clinical Research, Pharmacovigilance, Biostatistics and Commercial operations.

Responsibilities:
  • Clinical Trial Authorisation applications
    • Preparation and submission for regulatory approval of clinical trial authorisation applications
    • Maintenance of existing clinical trial authorisations
    • Input in decision process regarding clinical trials conduct and strategy
    • Supervises regulatory CRO counterpart as applicable
    • Coordination of clinical study report activities as required
  • Pre-authorisation regulatory activities
    • Preparation and submission of meetings with Health authorities
    • Coordination of responses to Health Authorities
    • Support with regulatory strategy and communication
    • Support with registration activities
  • Post-authorisation regulatory activities
    • Preparation and submission of variations through centralised procedure
    • Labelling activities
    • Review of promotional materials and liaising with Marketing/ Medical Affairs
  • Regulatory Intelligence
    • Preparation and maintenance of a central source of Regulatory Intelligence information, including but not limited to therapeutic area and general EU and US regulatory guidance information
    • Preparation of Orphan Drug annual reports for EU and US
    • Coordination of periodic reports or other update to regulatory documents as required, e.g PSUR, RMP, IB, CCDS.
  • Document management
    • Filing and archiving the regulatory documents according to SOPs
    • Maintenance of electronic filing systems
    • Maintenance of internal regulatory database


Requirements:
    • Mandatory previous experience in a pharmaceutical company or a CRO
    • Minimum Bachelor degree in life science
    • Minimum 3-5 years of experience in a similar role, responsible for EU regulatory affairs
    • Demonstrated experience in regulatory activities in centralised procedure
    • Experience in clinical trial applications
    • Previous experience in orphan drugs will be highly appreciated
    • Knowledge of EU and FDA regulatory affairs guidelines & regulations
    • Previous experience in operating within complex matrix organisations
    • Fluency in English, both written and oral


Keywords: post marketing authorisation,centralised procedures, regulatory affairs, FDA, EMA, english

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start date
07/2017
Duration
12 Months
From
Real Staffing
Published at
30.06.2017
Project ID:
1370885
Contract type
Freelance
To apply to this project you must log in.
Register