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Regulatory Affairs Specialist Inizio Engage Calendar_Month Hace 5 Horas Place Madrid
hace 3 meses
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.
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
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.
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
Estudios mínimos Licenciado Experiencia mínima de 5 a 10 años Disponibilidad para viajar Ninguna
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