Regulatory Affairs Specialist

For our Pharma client in Basel we are looking for a

Regulatory Affairs Specialist

Main tasks:
Providing Local Regulatory Affairs staff with appropriate certificates, declarations and legalized documentation
Coordinating renewal requests from Local Regulatory Affairs
Properly tracking and storing regulatory documents and document Requests in the Document Management System
Compiling the regulatory contribution for PBRERs/PSURS
Proactively engaging Local Regulatory Affairs staff in projects when new registrations or changes to existing registration are required by providing documentation to support new registrations, renewals, variations, and other regulatory requirements, based on management guidance and planning.

QUALIFICATION:
Business or Scientific diploma or degree
1-3 years experience in a regulatory role
TOPRA (Introductory course) or similar preferred
Knowledge of European regulatory guidelines
Additional regional expertise preferred but not essential (LATAM, Asia Pacific, Middle East)
Strong organizational skills
Proficiency in MS Office: Word, Excel, PowerPoint
Ability to communicate effectively in English both verbally and in writing
Ability to work effectively within a cross-functional team
Customer orientation

START DATE: FEBRUARY 2019
DURATION: 1 YEAR
LOCATION: BASEL

Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)

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