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EU Regulatory Affairs Officer - VIE Contract (W/M)

date posted 09/16/2020
contract type Full time
job id R2565048
location Dublin, Ireland

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.

At Sanofi diversity and inclusion ia foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.

We are looking for: EU Regulatory Affairs Officer - VIE Contract (W/M)

The VIE will be responsible for managing EU regulatory activities on a dedicated marketed product with development of new indications under the supervision of a senior regulatory project manager.

Specific responsibilities include:

  • Develop the EU regulatory strategy and provide regulatory expertise within project/product teams
  • Participate and contribute to Regulatory sub-teams and be the regional regulatory representative in the Global Regulatory Affairs (GRA) multi-function teams
  • Define, Coordinate and contribute to the preparation Clinical Trial Regulation (CTA), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Report (DSUR) and and/or any type of responses document to Health Authority questions with the stakeholders (Non clinical, clinical, Medical, Pharmacovigilance, etc.),
  • Provide support to the regulatory project manager for preparation and coordination of major regulatory document such as scientific advices, Orphan drug designation, Paediatric Investigation Plan (PIP), etc.
  • Ensure maintenance and compliance of regulatory activities
  • Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

Candidate's profile:

Education:
Physician, Pharmacist or Life Sciences Degree with a Master in Regulatory Affairs

Experience:

Comprehensive knowledge and operational expertise of the EU regulations with at least demonstrated 6 mths experience in similar function

IT skills:

  • Proficiency with MS Office Package
  • Knowledge of Veeva would be a plus

Languages: Fluent in English

Other desirable skills:

  • Ability to work with multi-functional 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 pro-activity

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.

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