Regulatory Affairs Director

hace 3 semanas


Madrid, España MCR International A tiempo completo

**CLM-2210-83**
**REGULATORY AFFAIRS DIRECTOR**
**MADRID**

From MCR International, we are looking for a **Regulatory Affairs Director** for a well known Pharmaceutical company based in Madrid with the possibility of working remotely 50%.

**Mission**:
Define and implement the regulatory strategies to obtain marketing authorizations for the company's investigational drugs.
Provide regulatory advice in the research and development and post authorization stages in order to optimize the development plans and the maintenance of the marketing authorization

***Responsibilities**:

- Design external and internal communication strategies regarding regulatory aspects of drugs under investigation and/or marketed.
- Establish a regulatory strategy aligned with the policy of the company and other internal departments.
- Develop and implement global regulatory strategies to accelerate and optimize regulatory processes during the development, commercialization and life cycle of products.
- Define strategies to manage regulatory risk (eg identifying and minimizing/avoiding the risks arising from existing or new regulations) for both investigational drugs and drugs marketed by the company.
- Participate in the approval of promotional materials ensuring compliance with current regulations and legislation.
- Manage personnel of the Department and budget, including review and update of job descriptions and functions, definition and review of objectives, performance evaluation of collaborators, development and training of collaborators.

**Position Requirements**
- Bachelor Degree in Pharmacy, Biology or Medicine.
- Master in Regulatory Affairs.
- High level of English and Spanish.
- 10 years managing international registration processes in products for human use with the European Medicines Agency, FDA or similar institutes.

Detalles / Details

Ciudad / City
Madrid
- País / Country
ESPAÑA


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