Regulatory Affairs Officer

Sanofi

Helsinki, Finland

About the job

As Regulatory Affairs Officer VIE within our Regulatory Affairs team, you will work within the Global Regulatory Affairs Department of the Sanofi Vaccines unit, participating in the missions of the Global Regulatory Affairs Traveler Endemic Vaccines Team. Locally you will work within the Finnish Regulatory Team, conducting regulatory activities for the affiliate.

Main responsibilities:

Coordinate of regulatory activities to support the product lifecycle or development plans and support the CTD task force.
Coordinate of regulatory activities to support the Global Submission Plan with the global product regulatory team (GRT), track and update Global Simultaneous Submission plan (GSS).
Participate in the preparation of consultations with authorities
Support the GRL for the meetings of the product regulatory team (GRT) composed of the different regulatory experts (Regulatory CMC, Regulatory Labeling, Regional Regulatory contacts, Regulatory Operations): preparation, meeting minutes, follow-up of actions.
Support the Global Regulatory Lead (GRL) for the update of the document summarizing the Global Regulatory Product Strategy (GRPS).
Support the local regulatory team in all relevant regulatory activities.

About you

Experience:

1-2 years of experience in pharmaceutical regulatory affairs or significant internship in the field.
Experience in an international environment is appreciated.

Soft and technical skills:

Knowledge of pharmaceutical regulations & registration dossiers.
Understanding of regulatory submission processes, analytical and writing competencies
Strong AI skills and practical experience are desirable.
Ability to work autonomously.
Rrigor and adaptability.
Strong intercultural communication, teamwork skills.
Strong written and verbal communication abilities.