Head Regulatory Affairs
Sanofi Finland is currently inviting applications for the role of Head Regulatory Affairs.
The Head Regulatory Affairs leads the Finnish Regulatory team and is responsible for the Sanofi group regulatory activities including regulatory compliance, interactions with Health Authorities, Risk Management, etc in Finland.
We offer the opportunity to work with a diverse portfolio within an innovative company in a position which offers regional and European exposure.
The main responsibilities of the Head Regulatory Affairs include:
- Manage the RA function and define local RA priorities
- Ensure advice and input is provided to local business strategies with regards to regulatory feasibility, requirements and timelines
- Ensure high quality submissions within timelines agreed with global regulatory affairs, business and/ or health authorities
- Lead, motivate and develop the local RA team, and ensure the RA team members maintain and develop their regulatory skills and keep up-to date with the national and European regulatory environment by appropriate trainings
- Ensure quality and compliance of local regulatory activities in line with global regulatory affairs, national and European regulations
- Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development
- Act as the primary interface between the company and local regulatory authorities building good relationships in order to make Sanofi a recognized partner
- Give Input to global regulatory affairs for drug development with regards to local needs.
- Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material
- Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies
The essential criteria for the Head Regulatory Affairs are:
- Possess a Master Education in Pharmacy or a relevant Life Science Discipline
- Have at least 5 years’ experience in the pharmaceutical industry, including within Regulatory Affairs at affiliate level
- Possess people management experience
- People developer – display the full potential of your team
- Fluency in Finnish and English is a must, Knowledge of Swedish is a plus
- Ability to cooperate transversally - with RA colleagues cross countries and business partners across the organization
- Act for change - Embrace change and innovation and initiate new and improved ways of working
For more information about this position, please contact Wouter Blancke on email@example.com or via +32484307022.
- Ilmoitusnumero: 1096394
- Työsuhde: Vakituinen työsuhde
- Työn tyyppi: Kokopäiväinen
- Hakuosoite: www-osoite
- Sijainti: Helsinki