Sanofi Group Submission Planning Manager in Bridgewater, New Jersey
The Americas Platform Submission Management Team culture is focused on a deep commitment to operational excellence. Maximizing team growth via training and development as a standard strengthens our regional submission capabilities and continuously helps us reach new levels of effectiveness. Harnessing new technologies and applying them to our processes drives further efficiency that supports our ultimate responsibility: progressing the pipeline via timely and high-quality submissions to Health Authorities. The Submissions Planning Manager role is integral to the success of Americas Platform submission activities, as follows:
Role includes supervisory responsibilities for a team of dossier specialists and coordinators.
Oversees standards and process efficiencies for submissions and support effective change management communications; will be assigned Subject Matter Expert topic(s) as lead or on a task force.
Authors, revises/updates and maintains internal process and quality documents.
Trains team members as needed on processes.
Will apply subject matter expert advice and support on major/priority submissions as needed.
Partners with Publishing Lead to provide oversight and management of third-party vendors to support regulatory submission goals and quality.
Oversees on-boarding of new Submission Planning Coordinators and Submission Planning Managers and related on-boarding documentation procedure and documentation.
Globally partner with other regional platforms to share one vision in regulatory operations excellence.
Direct Submission Management Activities:
With a continuous process improvement team mindset, efficiently deliver top quality and timely submissions to North American health authorities.
High-level oversight of any priority/major submissions in the Americas Platform to confirm that all processes and procedures are being followed, that timelines will be adhered to and all Sanofi and Health Authority standards are being met based on the submission type.
Ensure staff is delivering these priority/major submissions in a timely and high quality fashion.
Manage strategic outsourcing model(s) that leverage support to balance workload; monitor and document these processes and efficiencies and confirm timelines for compliance submissions are being met.
Provide subject matter expertise in dossier types and processes with responsibility for training and mentoring staff, as needed.
Support submission and technical issue resolution, as needed.
Participate in project teams, working groups and/or task forces, as required.
Drive Operational Excellence:
Support a focused, quick acting, flexible and unified Americas submissions team; stay up to date with industry changes and trends and continuous meet organizational pipeline submission demands.
Assist in compilation of departmental metrics and performance goals.
Strive for continuous improvement and development of systems and procedures. Conceptualize new processes to drive efficiencies.
Develop, author and maintain supporting procedural documentation and tools for regulatory submission assembly (user guides, process maps, checklists, work instructions, SOPs).
Collaborate transversally with stakeholders and utilize new technologies to their highest capabilities, while maximizing team potential via training and development opportunities.
Mentor direct reports and team members, as needed.
Manage direct reports’ performance, as per objectives and goals and assessments.
Manage third party vendor performance and workload.
Skills and Competencies:
Proven ability to use excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization.
Ability to manage simultaneous priorities and lead complex projects and timelines in a matrix team environment.
Strong attention to detail and accuracy.
Possess strong knowledge of the drug development process and global regulatory regulations and guidelines.
Demonstrated and recognized capacity to identify critical submission or publishing issues and propose creative and achievable solutions; determines the causes and find efficient solutions.
Demonstrated leadership abilities with strong negotiating/influencing skills and effective people management.
Apply project management skills to appropriate activities.
At least a Bachelor’s Degree, or equivalent, in regulatory affairs, the sciences or related areas of study.
Experience in the pharmaceutical industry with at least 8+ years of diverse regulatory experience; regulatory operations experience a plus with technical aptitude with various software/troubleshooting.
Demonstrated ability to lead teams and transversal/cross-functional projects, as well as external partners/ CROs.
May require domestic or international travel.
Able to operate with discretion and confidentiality about sensitive data.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.