Regulatory Affairs Specialist Senior

il y a 5 jours

Massy, France CENTRE EUROPEEN DE RECHERCHE CARDIOVASCULAIRE Temps plein

**Regulatory Affairs Specialist**

The Regulatory Affairs Specialist is responsible for regulatory activities of clinical trials managed by CERC worldwide. You will work closely with the CERC Regulatory Affairs Manager and CERC Clinical Project Manager and make valuable contributions to the development of innovative techniques, concepts, and treatments to improve patient care and lives.

We’re looking for an enthusiastic team player who will focus on:

- Preparation and submission of regulatory documents to Competent Authorities, Ethics Committees and other regulatory bodies, as needed
- Providing technical and regulatory expertise for the preparation of submission documents
- Carrying out regulatory intelligence, in collaboration with the Clinical Operations Manager
- Contributing to the maintenance of the CERC Quality and Process Management System

**Qualifications**:

- University Degree within a Scientific/Healthcare discipline
- Relevant experience in Clinical Research and previous working experience in regulatory submissions of clinical investigations to Competent Authorities and Ethics Committees in various (European) countries
- Excellent communication skills in English and ideally in another European language (Italian, Spanish, German)
- Proficient in using personal computer, including using software such as Microsoft Word and Excel

**What’s in it for you?**
- Flexible working hours
- Free soft drinks (organic tea and coffee)
- Free organic fruits
- Multicultural environment
- Eco-friendly company
- Regular in-house training sessions
- Homeworking possible 2 days a week

At CERC, you will be part of a close-knit organisation, you will have the opportunity to learn and interact directly with different teams (Clinical Operations, Quality Management, etc. ). We have a friendly and open collaborative culture and a united team vision.

You will help in the creation of new innovative solutions to improve patient care.

Positions are based in Massy, a dynamic city close to Paris which is part of the “Grand Paris” project, with numerous transportation options (close to Orly Airport and “Massy TGV” train station).

**Job Types**: Full-time, Permanent
Status: Cadre

Pay: From 55,000.00€ per year

**Experience**:

- Clinical Research: 4 years (required)

**Language**:

- Anglais (required)

Work Location: Hybrid remote in Massy (91)

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