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Oferta de empleo en Dinamarca (Københavns omegn) de Farmacéuticos

Senior Regulatory Affairs Professional – Ra Cmc Devices

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos.

Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for sundhedsområdet : Andet sundhedsarbejde : Farmaceutarbejde

Descripción de la oferta de trabajo:

Do you want to be part of the transformation of LEO Pharma?

LEO Pharma has set the highly ambitious goal to become the world’s preferred dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter new business areas e.g. biologic treatments.

You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and develop the drug-device combination area.

The job

As Senior RA professional - CMC Device you will represent Global Regulatory Affairs with respect to the device constituent part of drug-device combinations responsible for providing strategic and operational regulatory input for established and new products during life-cycle management and development activities.

Your primary tasks will be to:

  • Provide regulatory device input to the development of global regulatory strategies in collaboration with RA CMC.
  • Participate in Life-Cycle Management and product development activities in cross functional project teams, responsible for regulatory compliance of the documentation supporting the device constituent part in relation to changes, authority interactions, and drug-device submissions including Notified Body Opinion.
  • Identify and evaluate regulatory issues and impact and liaise with the project team to ensure issues are addressed.
  • Increase understanding and impact of the changing regulatory landscape of medical devices and drug-device combination products with stakeholders.

Your qualifications

You are degree qualified within science e.g. pharmaceutics, biomedicine, or biomedical engineering with well-founded experience within the regulatory area for medical devices or combination products including solid knowledge of the device/drug-device regulatory framework and design control as well as sound understanding of the drug development process as well as life-cycle management. As a person you thrive in a busy environment; you are flexible and robust to changes. You have a strategic mindset and global perspective, and you have excellent stakeholder management skills; collaborate, communicate effectively, and build partnerships to meet shared objectives.

Your new team

RA CMC Device is a small team with a great passion for the drug-device regulatory field. CMC Device is part of Global RA CMC responsible for the device aspects of LEO Pharma’s products. Our vision is to be a strong strategic and supporting partner throughout the development and life-cycle of our products.

Contact and application

We will review applications on an ongoing basis so please don’t hesitate in sending us your application along with a short cover letter via our website. The deadline for application is 27. September 2020. If you have any questions, you are very welcome to contact Cecilie Bengtsen on +45 31702129, RA CMC Device.

País del trabajo: Dinamarca.

Región: Københavns omegn.

Ver 557 ofertas de trabajo en "Københavns omegn" (Dinamarca).

Número de puestos: 1.

Tipo de puesto: Contratación directa.

Tipo de contrato: Jornada completa.

Empleador: LEO PHARMA A/S.

Instrucciones para solicitar:

Please apply using one of the specified channels

Forma de contacto:

  • Ciudad: Ballerup; Código postal: 2750; Calle: Industriparken, Número: 55
  • Sitio web:

Identificador de la vacante:5203200.

Ver las 65 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos ofertadas.

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