About Sanofi Business Services In 2019 Sanofi Hungary was awarded Top Employer for the 2nd time while the same year Sanofi received the Global Top Employer award the 1st time in history. / while the same year Sanofi became a certified Global Top Employer the 1st time in history.

Sanofi is a global pharmaceutical leader providing healthcare solutions in more than 170 countries around the world. Sanofi has over 100 000 employees representing 145 nationalities worldwide.

The core purpose of Sanofi Business Services is to drive transformation and digitalization to enable best in class service delivery. Together we are to create value - we facilitate the work of business divisions to focus on their core competencies so that Sanofi can provide the best healthcare possible. Every day, you will experience what it means to make a strong contribution to the transformation journey which will empower the life of our patients. We offer the best in class benefits, and the opportunity to develop your own career whilst ensuring a healthy work-life balance.

The offices of Sanofi Business Services are in Váci Greens, in the heart of one of Budapest’s most famous business districts. The site offers a comfortable, sustainable and friendly working environment with community areas, gardens and bicycle storage. It is easily accessible by transportation; the site is between Gyöngyösi utca and Forgách utca metro stations.

If you want to join a purpose driven company that has empowering life of patients as its core, then explore our opportunities in Sanofi Business Services!

THIS IS OUR SANOFI. DISCOVER YOURS.

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.

CMC Product Manager (Biologics and Vaccines)

JOB PURPOSE:

This role will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical products for the Sanofi portfolio. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams.

KEY ACCOUNTABILITIES:

  • Responsible for developing innovative regulatory strategy and assuring this regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality
  • Coordinate with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management. Possibility to lead or coach a team of regulatory professionals
  • Create collaborative working relationships with Global Regulatory Affairs (scopes: corporate, regional, national), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management, Regulatory Health Authorities
  • Manage new applications for biologics through planning, preparation, submitting, reviewing support for product dossiers
  • Lead the license maintenance with annual reports (US, Canadian NDC and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
  • Oversee the regulatory strategy development by ensuring the preparation and review of submissions, the technical review of site supporting documents (CoA, SMF, MBR, SOPs), the notification of Reg Ops for publishing and dispatch to Health Authorities, the interaction with EMA and EU member states BoH on CMC topics
  • Evaluate Global Regulatory CMC strategies and risks to develop projects and/or marketed products. Work closely with the CMC teams to achieve implementation of appropriate regulatory strategies with regards to the financial impact and all identified risks

REQUIREMENTS:

  • Strong English knowledge
  • Bachelor or ideally Master’s scientific, healthcare or life sciences degree, RAC certification is an asset
  • 5+ years of experience in a regulatory function within a matrix environment
  • Knowledge and experience of EU, FDA, and global regulations
  • Experience with biological products
  • IT skills: MS Word, Excel, PowerPoint, MS Project, and Trackwise
  • Strong organization and communication skills within a matrixed organization
  • Demonstrated ability to effectively influence leaders and team members.

 

Cégnév: Chinoin Zrt. / SANOFI AVENTIS
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