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International Regulatory Affairs

Nombre de la empresa: Kelly Científico - Madrid

Ubicación

Población: Madrid
Provincia: Madrid
País: España


Descripción

Puesto vacante: International Regulatory Affairs
Categorías:
Sanidad y salud - Profesiones sanitarias
Departamento: International Regulatory Affairs, Pharmaceutical c
Número de vacantes: 3
Descripción de la oferta: Kelly Scientific Resources, the global leader in Human Resources solutions for the Chemical & Pharmaceutical Industry, is looking for candidates for 3 positions in the International Regulatory Department of a pharmaceutical company located in Madrid (SPAIN).

Specific accountabilities for this position include:

- Definition of the registration strategy for target countries.
- Direct interaction with local Regulatory Units, R&D, Clinical Research Team, Sales and Marketing, etc in order to evaluate the strategy to follow.
- Supervise the local Regulatory Units in the preparation of Dossiers, in order to optimise the Dossier submission in the different countries.
- Advise the International Development Director to define the company’ strategy.
- Follow up of the Deficiency Letters to ensure a proper answer.
- Ongoing review and communication of new regulatory requirements and variations.
- Define and control the budget assigned.


Requisitos

Estudios mínimos: Licenciado - Farmacia
Experiencia mínima: Más de 5 años
Requisitos mínimos: - University Degree in Pharmacy.
- At least 5-8 years experience in Regulatory Affairs, developing and implementing registration strategies, preferably in multinational Pharmaceutical companies with wide distribution.
- Previous experience in Non-Regulated Markets.
-- Fluency in written and spoken English.
- Ability to plan projects and deliver to deadlines.
- Flexible and able to accommodate changes in priority.
- A dynamic personality who is willing to “run with the ball”, and has proven ability to make things happen.

Requisitos deseados: - University Degree in Pharmacy.
- At least 5 years experience in Regulatory Affairs, developing and implementing registration strategies, preferably in multinational Pharmaceutical companies with wide distribution.
- Previous experience in Non-Regulated Markets.
- Well-developed commercial awareness.
- Fluency in written and spoken English.
- Ability to plan projects and deliver to deadlines.
- Flexible and able to accommodate changes in priority.
- A dynamic personality who is willing to “run with the ball”, and has proven ability to make things happen.


Contrato

Tipo de contrato: Indefinido
Jornada laboral: Completa


Salario

Comisiones / incentivos: Competitive salary.