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