Lead, Regulatory Data

Job Title: Lead, Regulatory Data

Location: Cambridge, MA, Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. 

The Lead,Regulatory Data is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical and biotechnology regulatory knowledge to drive strategic projects.   

This position will prioritize acquisition projects and be part of the acquistion data migration core team acting as the Migration Lead representing the business.  The Migration Lead role is the business owner for the regulatory data migration at an operational level and ensures the migration goal is planned and executed effectively and in line with Sanofi business rules. Alerts or issues are escalated as appropriate.

This role will be responsible for developing solutions and managing projects to meet current and future data needs including the investigation and analysis of complex regulatory data / document issues.  Based on the investigation and analysis this position will identify root-causes of problems and recommends corrective action as needed.

This management role may oversee onshore, nearshore and offshore, permanent or contractor resources and builds effective partnerships across the Sanofi organization.   This position requires a strong understanding of regulatory data, its business use, Regulatory Information Management (RIM) system data models and the ability to analyze complex sets of data and their relationships, perceiving patterns.    Strong leadership, strategic approach to problem solving, and project management skills are needed for this role along with the ability to collaborate effectively with all users and stakeholders of Sanofi regulatory data.  This role reports to the Sr. Director of Data Readiness and Quality.

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?

Main Responsibilities:

Primary areas of responsibility include:

• The Lead, Regulatory Data role provides leadership, strategy, management oversight, guidance, mentoring and planning for resources, budget and timelines with relation to strategic projects with a focus on migrations as a result of an acquisition.  

• The Lead, Regulatory Data will serve as Migration Lead for specific M&A initiatives as well as maintain oversight over the M&A ways of working to ensure continuous improvemement.  In some instances, the Lead, Regulatory Data may serve as the User Project Lead (UPL), a PUMA role supporting the technical data and content migration.

Migration lead:

• This role will lead and manage at the operational level the business portion of the migration team for acquisitions and ensure the business requirements are met including ensuring business continuity as part of the strategy and planning of migrations.  

• Act as business plan owner for pre-scoping and scoping phase of migration, including the development and management of pre-scoping and scoping phase 

• Identifies data and documentation to be migrated to Sanofi Vault RIM or other systems as appropriate, including the location of the relevant data and documents.

• Leads/facilitates meetings between Sanofi and legacy business SMEs, identifying migration scope and goals via scoping exercises with legacy company.  Liaises with business leads and represents them during Project meetings

• Collaborates with Digital to identify and build Project Team for migration

• Supports the planning and execution of migration as part of the larger project team

• Defines requirements for support from DOX, Data Governance, Submission Expert , SMEs/ business analyst (UPL), and coordinates work effort as needed

• Track status, business issues and risks, escalating issues when appropriate

• Continuously improve the migration process and framework.

Strategic Projects/Initiatives

• Identify and lead strategic projects/initiatives, or act as User Project Lead (UPL) as per Sanofi’s PUMA methodology

• Manage global cross-functional projects, setting and managing expectations with project sponsors, stakeholders and vendors

• Oversee the timelines and ensure goals are accomplished per agreed charter and meet the required quality standards. Identify possible interactions with other projects / operations.

• Partner with various functions and organizations across GRA and Sanofi, as part of data investigations and data projects

• Prepare and deliver presentations as needed

• Finalize project documentation comprehensively

• As UPL, define user requirements, organize training, ensure acceptance and deployment of the solution from a user perspective, management of data enrichment to meet Sanofi’s current data standards, and manage all user activities

• Performs investigations of identified Quality Alerts and Quality Deviations.  Executes any identified Corrective Actions / Preventative Actions (CAPA).

About You

Knowledge, Skills & Competencies / Language

• Proven ability to lead teams and organizational functions, and to ensure projects are driven to completion

• Demonstrated collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness

• Strategic ability to design projects to address and resolve identified data issues and understand the risk posed by these issues

• Strong understanding of Regulatory data, data models, and systems along with an understanding of regulatory affairs life cycle (e.g., new product registrations, variations, extensions, pharmacovigilance, compliance, licensing)..

• Established ability to problem solve and analyze complex data issues.  Demonstrated critical thinking with the ability to construct investigations to collect data aimed to support a pre-determined hypothesis.

• Ability to partner transversally (across organizations and functions) in a fast paced, global and matrixed environment 

• A strong combination of people skills, regulatory business process and business data understanding, business and technical acumen, and project management skills 

• Keen organization skills – involves juggling multiple tasks and projects to keep everything running seamlessly

• Ability to communicate effectively, verbally and written, across varying functions and levels of management

• Prefer proven experience with recruiting, hiring, developing, coaching, mentoring, and managing people

• Demonstrated continuous improvement mindset

Qualifications

• Bachelor’s (University) degree in science, technology or information management.

• 7+ years’ experience in the bio/pharmaceutical industry with experience in Regulatory Affairs.

• Strong knowledge of Regulatory Affairs/Operations domain, regulatory requirements and regulatory information systems.

• Prior management experience, leading multi-disciplinary teams

• Prior Project Management experience

• Experience in data analysis, Regulatory data

• Experience with RIM tools (e.g., Veeva VaultRIM) and Publishing tools

• Established ability to problem solve and analyze complex data issues.  Demonstrated critical thinking with the ability to construct investigations to collect data aimed to support a pre-determined hypothesis.

• GxP Computerized Systems experience

Challenges of the job

• Understanding complex Regulatory data issues, relationships across the data model, relationship to system functionality and processes

• Adjusting to changes in priorities, timelines and deliverable dates understanding impacts on business and technology of data issue and proposed solutions

• Dealing with diverse personalities, varying levels of organizational structure and managing expectations with timelines with global colleagues in various functions (e.g,. Regulatory Affairs, Industrial Affairs, Procurement, Regions, Affiliates, Digital, CROs and Vendors).

• Collaborating with pharmaceutical/biologic companies to deliver migration goals while establishing or strengthening business partner relationships and representing Sanofi as a leader in the industry. Anticipation of complex data requests that will arise.

• Working and collaborating with people with very different levels of understanding of data and systems, including those with basic, minimal understanding.

Why Choose Us?

• 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.

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.