REGULATORY MANAGER
MCR International | Executive Search
Responsibilities
Provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase.
Provide general regulatory advice and support to other departments.
Review and approve promotional and non‐promotional material to comply with local regulation, self‐regulations and internal policies and procedures. Advise the marketing teams on the promotional activities.
Support pharmacovigilance department on safety relevant matters in line with national requirements.
Support the Head of RA with developing and meeting the longer‐term goals for the department.
Main Accountabilities
Obtain marketing authorisations for new pharmaceutical products, working closely with area headquarters.
Maintain marketing authorisations as required.
Review of promotional and non‐promotional materials and activities in accordance with legislation, local procedures and codes of practice.




Regulatory advice and support to Brand Team on promotional materials content and activities.
Keep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry.
Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products; participation in affiliate Brand Teams regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products.
Provide regulatory support for the Brand Teams commercial divisions in all areas pertaining to product life‐cycle management and new product development.
Liaise with European Regulatory Affairs and Corporate groups on regulatory matters.
Liaise with national regulatory authorities as required.
Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Comply with the Company's policies and procedures to ensure consistency of the

📌 REGULATORY MANAGER (Madrid)
🏢 MCR International | Executive Search
📍 Madrid