Global Submission Manager

Sanofi • Morristown, NJ

12d

About The Position

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. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re 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?

Requirements

• 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.
• 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 is required.
• Working knowledge of drug laws, regulations and guidelines is essential.
• Ability to work across cultures.
• 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 GRA leaderships.

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.
• Leads discussions with stakeholders and submission task force teams involving electronic guidance issues to ensure an appropriate understanding of electronic submission requirements from a cross-functionally perspective, supporting successful 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.

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees