Global Submission Manager

About the job

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.

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.
• 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.

Requirements

• Bachelors degree in regulatory affairs, sciences, or related areas of study.
• 5+ years of experience in pharmaceutical or related 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 is required.
• High degree of knowledge of US regulatory submissions.
• Working knowledge of drug laws, regulations and guidelines is essential.
• Ability to work across cultures.

Preferred Qualifications

• 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.
• Maintain independent abilities to learn quickly and adapt to new technologies/environments.
• Self-starter, who motivates and negotiates with an agile and positive approach.
• Demonstrated leadership ability, with strong negotiating and influencing skills.
• Ability to lead complex projects and timelines in a matrix team environment.
• Ability to identify critical issues and understand complex issues and propose creative and achievable solutions through using appropriate information.
• Determines the causes and possible solutions to the problem.
• Strong attention to detail and accuracy.
• Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
• Ability to cultivate internal and external relationships.
• Applicable knowledge of the drug development process.
• Proficiency working in eCTD publishing tools, RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
• Experience with Veeva RIM.

Benefits

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. #GD-SA #vhd

Pay

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.