Regulatory Affairs Officer - VIE Contract W/M

Job description

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.

We are looking for a candidate for a VIE mission of:

Regulatory Affairs Officer - VIE Contract W/M

The candidate will be responsible for managing registered products and products under development, as the regulatory representative for Europe under the supervision of a regulatory project manager

Specific responsibilities include:

·  Develop, advocate the European regulatory strategy and provide regulatory expertise within project/product teams
·  Participate, contribute to regulatory sub-teams and be the regional regulatory representative in multi-functional teams
·  Define, coordinate, contribute to the preparation of CTA (Call to Action), IMPD (Investigational Medicinal Product Dossier), DSUR (Development Safety Update Report ) and/or any type of response document to Health Authority questions with the stakeholders
·   (Non-clinical, Clinical, Medical, Pharmacovigilance, etc.),
·  Provide support to the regulatory project manager for preparation, coordination and submission of major regulatory documents, such as scientific advices, orphan drug designation, PIP, etc.
·  Provide occasional support to regulatory procedures for life-cycle management products, including document preparation, coordination, submission, etc.
·  Ensure maintenance, compliance of regulatory activities, including completion of databases and internal processes
·  Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy

Candidate's profile:

Education:

·  Physician / Pharmacist / Life Sciences Degree

Professional experience:

·  At least 6 months of experience on similar function
·  Comprehensive knowledge and operational expertise of the EU regulations

IT / hard skills:

·  Good knowledge of MS Office package software

Soft skills:

·  Ability to work with multifunctional and multicultural teams
·  Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
·  Ability to communicate effectively and efficiently with other functional departments in the business.
·  Good relationship ability
·  Ability to resolve issues and proactivity

Languages :

·  Fluent in English

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.