Sanofi Group Head of Regulatory Foundation Solution Center in Bridgewater, New Jersey

Scope of responsibilities and job profile for the head of Regulatory foundation Solution Center:

  • Within the Regulatory Affairs functional area, organize, manage, optimize and coordinate the activities of a team (internal/contractors/external partners) in line with the Business and ITS strategy.

  • Run the ITS Regulatory functional domain activities efficiently (governance, operations, budget, SLA …).

  • Deliver services and solutions aligned with ITS Business Partners needs and operational excellence objectives

  • The Head of the Regulatory Foundation Solution Center reports to the Head of Global Solution Center (GSC) Clinical, Regulatory and cross-functional and is a member of the GSC leadership committee.

Main Functional scope:

  • Regulatory Product tracking

  • Regulatory planning

  • Regulatory Document management

  • Submission Management

  • Management of Promotional material

  • Regulatory intelligence and Policies

Contribute to the strategy development and Implementation:

  • Contribute to define the long-term ITS vision, strategy and plans to best support business

  • goals of the Regulatory functional domain

  • Implement the developed strategy roadmap

  • Contribute to design, implement, animate and adapt the ITS Solution Center governance

  • processes and operating model

Business Alignment:

  • Define ITS services catalog related to Business requirements.

  • Implement the appropriate services to ensure optimal allocation of all available capabilities

  • Establish appropriate KPIs (shared with the Business) to measure customer satisfaction

  • Propose innovative solution to address new business needs or optimize current delivery

Delivery Management and Quality of services:

  • Oversee all ITS activities

  • Monitor appropriate resources allocations

  • Plan the workload and monitor the budget

  • Participate in drawing up service contracts / SLA and ensure compliance with commitments

  • Participate in the definition of indicators for performance and quality of service, monitor and communicate them

  • Communicate regularly achievements with business value driven mindset

  • Manage preventive / corrective maintenance

  • Ensure that standards and recommendations for Quality, Security and Accessibility of ITS are correctly understood and applied

  • Ensure the compliance of the environments within the area in relation to legal and regulatory requirements

People Management:

  • Coordinate, inform and lead the team

  • Facilitate the transfer of know-how, experience and best practice within the team

  • Review talent and skills development and support people development

  • Contribute to ITS recruitment within the functional domain

  • Ensure that teams are fully aligned with HR, Procurement, etc. rules and that best practices are implemented

Basic Qualifications:

Bachelor's degree in computing, computer science or related scientific or technical discipline.

Minimum 10 years relevant experience

OR

Master's Degree and minimum 6 years of related experience.

Sanofi US Services, 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.

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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