REGULATORY AFFAIRS MANAGER

MFC- REGULATORY AFFAIRS MANAGERMADRIDOverall responsibilities

To provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase.

To provide general regulatory advice and support to other departments.

Review and approval of promotional and non-promotional material to comply with local regulation, self-regulations and internal policies and procedures. To advice the marketing teams on the promotional activities.

Support pharmacovigilance department on safety relevant matters in line with national requirements.

To support the Head of RA with developing and meeting the longer-term goals for the department.

Main Accountabilities

Obtain marketing authorizations for new pharmaceutical products, working closely with area headquarters.

Maintain marketing authorizations as required.

Review of promotional and non-promotional materials and activities...