Global Submission Manager

Role Summary

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 Blue Print model, to provide key input into development plans. Responsible for operational submission planning and associated decision making for assigned products/submissions, prioritizing workload and negotiating timelines with key stakeholders.

Partners closely with Publishers/Submission Associates to execute the preparation of submissions according to plan. For Global Simultaneous Submissions (GSS), collaborates in an agile model with the Submission Lead and global colleagues to provide regional expertise and execute global filing plans.

• 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 Blue Print model.
• Represents GRO Global Submissions Management on Submission Task Force (STF) meetings for major/complex submission filings and collaborates with regulatory focal points on the ops-specific details of lifecycle submissions.
• Leads discussions with stakeholders and submission task force teams on electronic guidance issues to ensure understanding of electronic submission requirements from a cross-functional perspective, supporting successful submissions. Manages submission component receipt and adherence to submission preparation completion.
• Directs publishing activities for the portfolio to ensure high quality and timely submission delivery aligned to Sanofi and Health Authority standards.
• Partners with Submission Leads and global colleagues to deliver high quality and timely Global Simultaneous Submissions (GSS) filing plans, providing regional expertise.
• Acts as Subject Matter Expert (SME) in audits/inspections, special projects and issue resolution for regional activities.
• Interacts with GRA and Digital functions as SME for current processes/data/technologies, and evaluates and implements new/emerging technologies and requirements.
• May be assigned supervisory responsibilities.

• Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study.
• Minimum 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.
• Working knowledge of drug laws, regulations and guidelines.
• Ability to work across cultures.

• Expert knowledge of global submission standards and specifications.
• Strong understanding of global regulatory requirements, submission processes and the drug development process.
• Experience in planning, coordinating and managing different stages of submission development.
• Expertise in the eCTD process, document management environments/systems, publishing tools and submission software.
• Ability to learn quickly and adapt to new technologies/environments.
• Self-starter with proactive, agile approach.
• Demonstrated leadership, with negotiating and influencing skills.
• Ability to lead complex projects and timelines in a matrix team environment.
• Ability to identify critical issues and propose creative and achievable solutions. Strong attention to detail and accuracy.
• Excellent verbal and written communication skills; ability to communicate effectively at multiple levels in the organization.
• Ability to cultivate internal and external relationships.
• Applicable knowledge of the drug development process.
• Proficiency in eCTD publishing tools, RIM systems, MS Windows environment and MS Office with Adobe Acrobat.

• Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study.

• Strong command of the English language, both spoken and written.
• Ability to operate with agility in a dynamic global environment.
• Ability to maintain discretion and confidentiality about sensitive data.
• Ability to communicate and collaborate on many levels, including issue escalation to leadership.