Global Submission Lead

About the role

As Global Submission Lead within our R&D team, you will be responsible for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities for assigned programs at Sanofi. This position ensures optimal expertise on all dossier formats, standards, navigation, and life cycle management globally.

Responsibilities

• Lead 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 and actively participating in Global Regulatory Product Teams as part of the GRA BluePrint model.
• 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.
• Lead the creation and maintenance of submission plan based on a thorough understanding of publishing tools and processes.
• Lead 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, Guidance Documents, 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.
• Drive Operational Effectiveness 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.

Requirements

• Bachelor's degree, or equivalent, in regulatory affairs, life sciences, or related areas of study.
• 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 strong understanding of global regulatory requirements and submission processes is required.
• Working knowledge of drug laws, regulations and guidelines.

Skills

• Ability to work across cultures is required.
• Past experience in regulatory submission planning is preferred.
• Applicable knowledge of the drug development process is a plus.
• Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
• Knowledge of Veeva Vault is a plus.

About You

Self-starter with strong leadership skills, who motivates, has tact, diplomacy, and a flexible and positive approach.

Ability to lead projects and timelines in a matrix team environment.

Strong attention to detail and accuracy.

Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.

Additional Requirements of the Job

• 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.

Pay

Commensurate with demonstrated experience.

Schedule

N/A