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Regulatory Consultant - Clinical Trial Application - Phase III

26.03. | Employee | 10%

Temporary onsite consultant for the regulatory review and coordination of Phase 3 Clinical Trials.

Regulatory Consultant - Clinical Trial Application - Phase III

Global pharmaceutical company.

Missions

- Assist with core Clinical Trial Application package review

- Responsible to ensure harmonization of worldwide local CTA packages with the validated core CTA package

- For national specific forms and information: perform a critical analysis prior to reviewing the document with Regulatory Affairs Project Manager in charge

- Ensure adherence to Good Clinical Practice and all applicable local and international regulations

- Responsible to archive submitted dossiers, communication received from the authorities (queries, letter of approval"¦)

- Responsible to maintain and create tracking tools, enabling all departments in the strategical decision-making process

- Upon requests, perform review of CTA major amendment to ensure timely submissions

- Keeps informed about key regulatory trends and change in regulation regarding CTAs

Profil du candidat

- Hands on experience of Clinical Trial preparation and submission in Europe and Rest of the World countries

- Solid knowledge of GXP regulations

- Past experience in working with a CRO

- Experience with MS Office products and database applications required.

Conditions et Avantages

To be discussed.

26.03.2020
Employee, 10%

Contact

Michael Page Switzerland

Quai de la Poste 12 1204 Geneva

1204 Lausanne


Michael Page

Quai de la Poste 12Genève

Industry

Human resources / Personnel services

Michael Page

Quai de la Poste 12Genève

Industry

Human resources / Personnel services
Salary

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