(Poistunut julkaisusta)

Regulatory Affairs Manager
Sanofi Finland

Alkuperäinen julkaisupäivä 22.5.2018

Purpose of Role:

  • Be a member of the Finnish regulatory unit and be a part of the Nordic and Baltic regulatory team
  • To manage the regulatory activities for the defined products; the product portfolio can consist of both pharmaceutical and non-pharmaceutical products
  • The position is part of the Regulatory/ Finland-team and has a solid reporting line to Country Regulatory Head; the position is based in Espoo, Finland

Responsibilities:

  • Participate in local preparation of submissions of applications for new drug applications, variations and renewals
  • Do the preparation and submission of applications efficiently respecting the timelines and according to EU and national regulations
  • Be responsible to maintain the marketing authorisation for defined product (variations, renewals, packaging material)
  • Handle the co-ordination of questions from FIMEA and answers to FIMEA for applications
  • Handle translations of SPC and PIL, packaging material texts into Finnish and Swedish
  • Actively take part in multifunctional teams and meetings
  • Maintain effective liaison with both external stakeholders, as regulatory authorities, and internal stakeholders, as Marketing, Supply Chain, Safety and Medical Information, Quality, Market Access, CSU departments and Responsible Pharmacist

Qualifications:

  • Suitable degree in a relevant field of Life Science, such as pharmacology, biology or biotech
  • Several years of experience within Regulatory Affairs
  • Excellent interpersonal and communication skills in Finnish and English, Swedish is considered as a plus
  • Organization and planning skills
  • Team player and a flexible and positive attitude
  • Computer literate

If you have any questions, please direct them to the recruiter Marta Oller at Marta.Oller-ext@sanofi.com.

You can also call the Hiring Manager (Cia Ramstrom) directly. She will be awailable on Friday 1st of June between 10.00 and 12.00 am, and on Friday 8th of June between 10.00 and 12.00 am under the number +358 40 578 6818.

At Sanofi diversity and inclusion is 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.

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference. 

The values we are live by are teamwork, courage, respect and integrity.