Submission Manager - INT eCTD (Budapest)

Submission Manager - INT eCTD (Budapest)
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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.

Submission Manager - INT eCTD

JOB PURPOSE:

The Submission Manager applies regional expertise in managing all submission types for the regional GRA portfolio, from standard to complex. They represent GRO on Global Regulatory Teams (GRTs) for assigned products, per the GRA BluePrint model, to provide key input and has appropriate insight into the development plans for the products. The Submission Manager is responsible for the operational submission planning and associated decision making for assigned products/submissions, coupled with ability to prioritize workload and negotiate timelines with key stakeholders. They also partner closely with Publishers/Submission Associates to execute the preparation of the submissions according to plan. For Global Simultaneous Submissions (GSS), they partner in an agile model with the Submission Lead and global colleagues to provide regional expertise and execute the global filing plans.

KEY ACCOUNTABILITIES:

  • Applies project management skills and regulatory knowledge for regional submission types, from standard to complex.
  • Applies expert understanding on all regional dossier formats, standards, navigation and lifecycle management, eCTD, and ICH.
  • Represents GRO Global Submissions Management on Global Regulatory Teams (GRTs) for assigned development and marketed products portfolio, per the GRA BluePrint model.
  • Represents GRO Global Submissions Management on Submission Task Force (STF) meetings for major/complex submission filings and partner effectively with regulatory focal points on the Ops-specific details of lifecycle submissions.
  • Leads discussions with stakeholders and submission task force teams involving electronic guidance issues to ensure an appropriate understanding of electronic submission requirements from a cross-functionally perspective, supporting successful submissions. Works within project teams in the control of submission component receipt and adherence to submission preparation completion.
  • Directs the publishing activities for assigned portfolio to ensure high quality and timely submission delivery aligned to both Sanofi and Health Authority standards.
  • Partners effectively with Submission Leads and global colleagues to deliver high quality and timely Global Simultaneous Submissions (GSS) filing plans, while also providing regional expertise.
  • Acts as Subject Matter Expert (SME) in audits/inspections, special projects and issue resolution for regional activities.
  • Partners with GRA and Digital functions as SME for current processes/data/technologies, as well as evaluating and implementing new/emerging technologies and requirements.
  • May be assigned supervisory responsibilities.

REQUIREMENTS:

  • Strong English knowledge
  • Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
  • 5+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience.
  • High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
  • Working knowledge of drug laws, regulations and guidelines is essential.
  • Stakeholder management experience on many levels

 

Budapest

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