Regulatory Affairs Specialist

We're looking for Regulatory Affairs Specialist in Madrid

Inizio Engage is looking for a Regulatory Affairs Specialist for an important and well known pharma company. Leader in develop, manufacture and marketing a wide range of generic and OTC products.

The Regulatory Affairs Specialist that we're looking for will be in charge of managing the Regulatory Affairs agenda at country level.

Working with inspiring and experienced colleagues for Iberian Cluster. You'll find an active, get-things-done, creative, inclusive culture.

Your mission:

- As part of Scientific Affairs team, you will have the opportunity to work with the Regulatory Affairs team at country level for Iberian Cluster.
- You will play a key role in ensuring the products are compliant with local and EU legislation, working with manufacturing, marketing and other teams from other parts of the world.

**Responsibilities**:

- Provide an efficient and proactive Regulatory service to meet the business objectives
- Support proactively commercialization of products
- Ensure agility in daily interaction with authorities and competitive intelligence.
- Cooperate closely with Central RA in regulatory Intelligence and policy area, submission planning and implementation of business excellence measures and business reporting
- Secure and timely complete new regulatory approvals in national and ( if relevant ) European approval processes
- Secure orderly and timely completion of all regulatory requirements to retain the registered product portfolio, its variation and, if decided, termination of app

Número de vacantes: 1

Modalidad de trabajo: Híbrido (25%)

"

**Requisitos**

Degree in farmacy (mandatory)

Estudios mínimos
Licenciado

Experiência mínima
de 5 a 10 años

Disponibilidad para viajar
Ninguna