Senior Regulatory Scientist

il y a 1 semaine

Paris, France VCLS Temps plein

Senior Regulatory Scientist.

We are growing our CTS group. This role will see you become a valued member of a supportive team and lead by a progressive leader with an authentic communication style who will steer and empower you to grow and develop personally and professionally.

Role overview
- Identify/coordinate the identification of the international, national, and/or local requirements applicable to concerned regulatory procedures for concerned countries
- Assist with the regulatory review (as per VCLS specific procedures) of the study core documents (e.g. protocol, Investigator’s Brochure, patient information leaflet/informed consent form, labels)
- Perform a quality control of the CTA packages before they are submitted
- Create and update/QC the study status tracking tool exchanged with client, and other internal tools
- Draft/QC response to client’s ad-hoc questions,
- Create/maintain/QC up-to-date knowledge management internal tools (memos, trackers, etc.)
- Liaise with regulatory authorities and/or service providers when appropriate, under supervision of the project manager/lead consultant
- Participate/lead regular video/teleconferences with client throughout the project to provide regulatory status updates of the study

**Requirements**:

- M.Sc degree equivalent or higher
- CRO or Life Science consulting experience
- Attentive to detail
- An organized /multitasker
- Project management

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