Global Submission Manager

Global Submission Manager

The Global Submission Manager applies global expertise in managing all submission types for the GRA portfolio, from standard to complex. 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 Global 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.

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Main Responsibilities :

• Applies project management skills and regulatory knowledge for global submission types, from standard to complex.
• Applies expert understanding on all 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.

Knowledge, Skills & Competencies / Language :

Qualifications :

Requirements of the job :

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.