Regulatory Affairs Manager

Regulatory Affairs Manager

Sanofi
2-5 years
Not Specified

Job Description



Job Summary / Mission:
  • Ensure the registration of new/renew/variation of assigned products/tasks are registered and maintained smoothly and timely (submission and follow up for approval online/paper with HA).
  • Up to date knowledge on regulatory regulations and implementation.
  • Ensure regulatory compliance internally (VAULT, Vista, 4M.) and externally (Health authorities in HN/HCM, Quality Institute) of assigned products/activities.
  • Ensure promotional and non-promo material is reviewed, approved as internal & local regulations

Main responsibilities:
  • Ensure the registration of new/renew/variation of assigned products/taks are registered and maintained smoothly and timely (submission and follow up for approval online/paper with HA).
  • Up to date knowledge on regulatory regulations and implementation.
  • Ensure regulatory compliance internally (VAULT, Vista, 4M.) and externally (Health authorities in HN/HCM, Quality Institute) of assigned products/activities.
  • Ensure promotional and non-promo material is reviewed, approved as internal & local regulations

About you
Experience:
  • Mandatory: previous experience in relevant position
  • Beneficial: at least 2 years in relevant position

Knowledge:
  • Regulatory
  • English: intermediate
  • Computer literacy

Core competencies:
  • Well-organised
  • Time management
  • Communication
  • Problem solving
  • Team spirit

Languages: English fluent, both written and oral
Others:
  • Education: Pharmacist, Medical Doctor, Biologist

Sanofi Behaviors and Skills
This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our and check out our Diversity Equity and Inclusion actions at !
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.

Job Details

Employment Types:

Industry:

About Sanofi

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.
Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Job Source : en.jobs.sanofi.com

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