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Submission Manager - INT eCTD

date posted 01/09/2022
contract type Full time
job id R2616147
location Budapest, Hungary

Subission Manager

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

#LI-EUR 

#GRAHUB

About Sanofi and Global Regulatory Affairs

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.

At Sanofi’s Global Regulatory Affairs, we’re ushering in a bold new era of regulatory affairs – one that is rooted in collaboration, driven by creativity, and inspired by tomorrow. As strategic partners with our 1.400 RA associated present in over 80 countries, we build regulatory strategies and timely execute our targets while establishing constructive relationships with health authorities and key stakeholders worldwide. We’re harnessing cloud-based systems and advanced technology to amplify the impact of our ambitious teams.

Are you looking for an opportunity to contribute to an agile, global regulatory team? To impact a broad and diverse portfolio of hundreds of products? To drive change at a company that is 100% full-scale all-in committed to transforming its technology base and reimagining the role of regulatory affairs? Apply to join our regulatory Hub and discover all that you can do.”

The offices of Sanofi GRA Hub 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.

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.

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