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Regulatory Affairs Manager at Thermo Fisher Scientific

Berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

02 Feb, 27

Salary

54000.0

Posted On

04 Nov, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Preparation, submission and management of national and European marketing authorization procedures (DCP, MRP, RUP) for medicinal products
Processing of variations, renewals, transfers of registrations and other lifecycle management activities
Creation, maintenance and updating of electronic registration dossiers (eCTD)
Examination of product information, instructions for use, labeling and packaging for regulatory compliance
Assessment and implementation of regulatory requirements for pharmaceuticals, medical devices, food supplements and cosmetics
Regulatory support for product launches, portfolio expansions, and business development and engineering projects.
Communication with authorities, partner companies and service providers
Maintenance of regulatory databases and use of electronic government platforms (e.g. CESP, PharmNet.Bund, EMA systems)
Participation in cross-departmental digitization, optimization and compliance projects
Supporting the quality management system through change controls and regulatory compliance measures

Responsibilities