Sanofi
biopharma
GlobalSubmissionLead
“Global Submission Lead at Sanofi. Skills: Global Submission Lead, regulatory submissions, eCTD, ICH, pharmaceutical industry, regulatory operations. planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities. ensures optimal expertise on all dossier formats, standards, navigation, and life cycle management globally”
What You'll Achieve.
seamless execution and delivery of high-quality regulatory submissions that support Sanofi's mission to bring innovative medicines to patients worldwide; ensure success in obtaining goals and ensuring business continuity; drive operational effectiveness for regulatory submissions
Industry & Context.
issue resolution
This position may require some domestic and international travel, This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data, This position requires successful collaboration on cross-functional teams and interactions with external partners
What They're Looking For.
Must Have
5+ years of experience in the pharmaceutical industry, related to regulatory operations or equivalent/relevant experience, High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers, is required, Understanding of Global Regulatory regulations and guidelines, i. e. FDA and EU regulations, and ICH guidelines, alongside understanding of global regulatory requirements and submission processes is required, Working knowledge of drug laws, regulations and guidelines, Ability to work across cultures is required, Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required
Nice to Have
Past experience in regulatory submission planning is preferred, Applicable knowledge of the drug development process is a plus, Knowledge of Veeva Vault is a plus
What You'll Do.
and tracking of regulatory Priority portfolio and Integration submission activities
ensures optimal expertise on all dossier formats
and life cycle management globally
leading the planning and delivery of worldwide regulatory submissions required to support the development and registration of new global products
Represent GRO Submissions Management in the development of global submission filing plans
actively participating in Global Regulatory Product Teams as part of the GRA BluePrint model
Acts as Regulatory Operations Team expert providing subject matter advice on ICH
and electronic submission requirements
as well as other pertinent regulatory guidelines relating to the format of regulatory submissions
Leads creation and maintenance of submission plan based on a thorough understanding of publishing tools and processes
Leads project teams to ensure the control of submission component receipt and workflow completion
Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
Ensure delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards
Remain fluent and current on global regulatory guidelines and approval processes
procedures and submission templates to ensure compliance with internal/external requirements
Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO peers
Provide oversight and manage vendors to support Regulatory submissions goals
Act as a key point of contact for leadership in establishing trusting partnerships with external co-developer pharmaceutical companies for implementation of e-Submission strategies between two companies
Ensure that the team follows and strictly adheres to
internal standards including Standard Operating Procedures
and Policies throughout the lifecycle of the application
Coordinate with Regulatory Operations external equivalent to develop milestones and timelines and ensures success in obtaining goals and ensuring business continuity
Support in the implementation of standards and process efficiencies for submission publishing and support effective change-management communications
May assist in the writing and review of process documentation
including SOPs and Policy documents
Oversee the continuous improvement
development and integrity of GRO systems and procedures
Lead and/or represent GRO in GRA special initiatives
How You'll Work.
Team & Collaboration
collaboration within GRA and with cross-functional stakeholders and external partners; Ability to lead projects and timelines in a matrix team environment; successful collaboration on cross-functional teams and interactions with external partners
Communication Scope
Excellent verbal and written communication ability to communicate effectively to multiple levels in the organization
Process & Methodology
planning, coordination, tracking, submission plan, project teams, milestones, timelines, lead projects and timelines
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