Regulatory Submission Lead

Regulatory Submission Lead

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Submission Lead is responsible for the planning, coordination, and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofis priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

Submission Management Activities :

• Act as key partner to the GRL and project teams by applying global submissions management expertise in the design, planning and delivery of the GSS filing plans for Sanofi R&Ds priority growth assets.
• Represent GRO on the Global Regulatory Teams for Sanofi GBU priority assets, per the GRA BluePrint model.
• Act as Project Leader for the GRO Submissions Management Task Force (SMTF), managing global colleagues in a matrix environment to ensure alignment, visibility and timely delivery across all platforms for the GSS filings.
• Accountable for the delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards. Provides analysis, tracking, communication and issue escalation / resolution on overall operational activities based on input from technical experts (Submission Managers, Submission Associates and / or Publishers).
• Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.
• Act as Regulatory Operations Team expert providing subject matter advice on ICH, eCTD, and electronic submission requirements, as well as other pertinent regulatory guidelines relating to the format of regulatory submissions.
• Remain fluent and current on global regulatory guidelines and approval processes, procedures and submission templates to ensure compliance with internal / external requirements.
• Direct and mentor trainees and interns.
• Partner and support Submissions Management Leadership in the management of GRO activity for Sanofi GRAs priority submissions portfolio, the submission forecast and ensuring proper staffing for upcoming submissions.
• Create and manage resourcing and budget plans, as needed.

Submission Partnerships and Integrations :

Drive Operational Effectiveness :

About You

Requirements :

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