Sanofi Group Head, Global Business Unit (GBU) Submission Management, Cambridge, MA in Cambridge, Massachusetts
The Head of Global Business Unit (GBU) Submission Management is a team leader with first line accountability for the quality, accuracy and timeliness of regulatory submissions for Sanofi’s GBU developmental portfolio. This role is responsible for setting the vision for assigned team and collaborating with GRA and GRO leadership to set goals, drive process efficiencies and overall operational effectiveness for regulatory submissions. The GRO Portfolio Lead also plays a key role in user requirements gathering and GRA special initiatives.
Duties & Responsibilities:
Direct Submission Management Activities:
Direct the GRO activity for Sanofi GRA’s priority submissions portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions.
Ensure staff is representing 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.
Ensure staff is delivering high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority standards.
Lead staff with interpretation of global regulatory guidelines and approve processes, procedures and submission templates to ensure compliance with internal/external requirements.
Mentor staff in creating high quality submission plans for major/complex submission filings.
Collaborate with leadership in GRO, GRA and R&D contributing groups to understand the global regulatory environment for Sanofi products and develop appropriate action plans for GRO.
Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring GRO staff.
Drive Operational Effectiveness:
Ensure staff adherence to the appropriate use of technical tools to ensure regulatory and internal compliance is preserved.
Define and implement standards and process efficiencies for submission publishing and design effective change-management communications.
Write, review and/or approve process documentation, including SOPs and Policy documents.
Collaborate with GRO leadership to develop departmental performance goals/KPIs and monitor progress regularly.
Oversee the continuous improvement, development and integrity of GRO systems and procedures.
Suport legal requests, product divestments, audits/inspections and related entities.
Forecast and manage to the Submissions Management budget.
Provide Subject Matter Expertise for technical publishing tools.
Lead and/or represent GRO in GRA special initiatives.
Interview, hire and train employees/consultants.
Manage direct reports’ performance by setting clear objectives and development goals, providing frequent feedback and conducting performance assessments.
Knowledge, Skills & Competencies / Language :
Proven success in leading teams and people management.
Strong understanding of global regulatory requirements and submission processes.
Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible 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.
Demonstrated project management skills, with the ability to integrate planning efforts across departments to ensure organizational effectiveness.
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
Ability to cultivate internal and external relationships.
Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
Applicable knowledge of the drug development process.
Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience
Experience in the pharmaceutical industry with at least 10 years of regulatory operations experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
Past experience in regulatory submission planning is required.
Working knowledge of drug laws, regulations and guidelines is essential.
Ability to work across cultures
Requirements of the job :
this position requires 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 leading cross-functional teams and interactions with external partners
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life