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Offers “Sanofi”

days ago Sanofi

Regulatory Affairs Officer (VIE)

  • Internship
  • Amsterdam, NETHERLANDS
  • Sales

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:

The Global Regulatory Affairs Europe Rare Blood Disorders team is responsible for the development, execution of the regulatory EU strategy for both development and marketed pharmaceutical products.

Projects for the coming 12-24 months include preparation, coordination and submission of regulatory documents such as clinical trial applications, scientific advices, etc. The VIE will work to support the team with this increasing peak demand of the above-mentioned regulatory activities.

Responsibilities and what we have to offier.

· Unique opportunity to work in international team at EU level in Global Regulatory Affairs (GRA) on interesting projects in the rare disease (rare blood disorder) area
· Managing projects for products under development
· Developing, executing regulatory EU strategy, provide RA expertise within project/product teams
· Defining, coordinating, contributing the preparation of Clinical Trial Applications (CTA), Investigational Medicinal Product Dossier (IMPD), Dev Safety Update Report (DSUR) and/or any type of response documents to Health Authority questions with the stakeholders (nonclinical, clinical, medical, pharmacovigilance etc.)
· Providing support to the regulatory project manager for preparation, coordination and submission of major regulatory documents
· Ensuring maintenance, compliance of regulatory activities for development products, including completion of databases and internal processes
· Representing EU RA within GRA and outside GRA multi-functional teams (global or regional)
· Following regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy

Education:

· Pharmacist / Physician / Veterinarian or Life Sciences Degree

Professional experience:

· At least 6 months of professional 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:

· Integrity & Trust
· Adaptable to change and flexible
· Problem solving including ability to communicate effectively and efficiently (both written and oral)
· Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
· Personal disclosure
· Approachable and open minded
· Courage and willing to learn
· Willing to perform diverse activities, including operational tasks, for instance formatting, regulatory systems etc.

Languages :

· Fluent 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.