REGULATORY CMC EXPERT

Descripción de la oferta

Job Description

-Preparation of variation packages for post-approval CMC changes for Pharma products under supervision of the Manager, RA Post-Approval Support & Site Regulatory Assessor. -Determination of the strategy for optimal roll out of CMC changes under supervision of the Manager, RA Post-Approval Support & Site Regulatory Assessor. -Ensure that documents for regulatory submissions are on time, complete, well-structured and of high quality and that they are presented to the markets in a way that facilitates the review by the authorities. -Coordination of MTO review for CMC changes where she/he is the Tech RA Lead. -Provides regulatory support to the manufacturing site Alcon Cusí, Barcelona. -Provides administrative support for any request. -Compile complete and well organized registration packages that meet current regulatory requirements in order to facilitate health authority approvals.
Position Title

REGULATORY CMC EXPERT

Perfil buscado

Minimum requirements

Master’s degree within an appropriate scientific/technical discipline.
Knowledge of current regulations of Pharmaceutical Industry.
Fluent in Spanish and English as business language is required.
Minimum 2 years of experience in Regulatory Affairs.
Job Type

Full Time
Country

Spain
Work Location

Barcelona
Functional Area

Research & Development
Division

Novartis Technical Operations
Business Unit

NTO QUALITY
Employment Type

Temporary
Company/Legal Entity

Alcon Cusí S.A