Principal Capability Professional For Regulatory End-To-End Processes, Regulatory Intelligence And Adprom Capabilities

Principia Biopharma Inc. Swiftwater , PA 18370

Posted 2 months ago

Title: Business Process & Operational Excellence, Principal Capability Professional

Reports to: Business Process & Operational Excellence Lead for Labeling, CMC & AdPromo, Regulatory Intelligence Management capability

Group: Global Regulatory Operations


GRA is enabled by capabilities made up of a combination of process, data, and technology. The Labeling, CMC & AdPromo, Regulatory Intelligence Management capability has a global footprint including eight (8) corporate sites plus the majority of affiliates. The Capability must be kept current, innovative and compliant with the constant changing Health Authority requirements to facilitate approvals of Sanofi products and their lifecycle management submissions. The capability enables the approval and compliance maintenance of Sanofi's products in 163 countries requiring 50,000+ submissions per year.


The Business Process & Operational Excellence Sr Process Analyst for Labeling, CMC & AdPromo, Regulatory Intelligence Management capability is a strong analyst who can combine consulting, process excellence, information modeling, modern Information Technology expertise with pharmaceutical and biotechnology regulatory knowledge to drive the ongoing transformation and continuous improvement for the capability.

This role is will be a driver for the ongoing innovation of process, information and technology initiatives that maintain compliant operations as well as modernize workflow for the capability. This is done in partnership with GRA corporate plus affiliates, contributing functions (PV, Clinical, non-Clinical, etc.) and Information Technology Services (ITS). The role will partner with these groups to influence future process, standards and technology evolutions. In addition to ensuring continuous improvement advances, the position will build internal and external partnerships for standards and technology evolution.

This role will be responsible for the identification, delivery and evolution of projects within this Capability. The role will be expected to possess a clear understanding of integrated, platform technology and work closely with process owners, stakeholders, ITS and external service providers to drive the evolution of the capability. The role will ensure the maximum benefit is gained from the capability through a continuous improvement model. As a strategic partner, the role will be a key champion and change agent. The role reports to the Business Process & Operational Excellence Lead for Labeling, CMC & AdPromo, Regulatory Intelligence Management.

Job Responsibilities:


  • Strong direct input to capability strategy and roadmap aligned to the Sanofi business objectives, Health Authority requirements and with the ITS corporate strategy

  • Develops and assures maintenance of end to end GRA process flows with an underlying information architecture

  • Advises and influences senior management on the marketplace evolution and potential application of information and technology, aligned to the overall GRA strategy

  • Represents Sanofi in relevant industry standards groups that interact with Health Authorities

  • Ensures compliance, audit readiness and operational stability

  • Addresses complex problems with broad implications for process and information architecture, balancing the often competing needs of standardization and innovation

  • Participates in decisions regarding resource alignment/dedication and prioritization (people resources, dollars/funding, project criticality) and communicates rationale

  • Applies compliance requirements within scope of responsibility, provides documentation as necessary, and participates in compliance activities as required

  • In close partnership with senior business stakeholders, facilitates governance processes.

  • Guides and mentors others inside and outside the organization order to help them deliver better business outcomes

  • Participate in internal audits and external inspections as a process and information expert for the capability

  • Key analyst for mergers, acquisitions and divestitures to evaluate current state and define plan and target state for process, data and systems plus any transitional states.

  • Provide Level 3 process support for this capability

Strategic Projects/Initiatives for these capabilities

  • Identify and lead strategic projects/initiatives

  • Manage from beginning to end large global cross-functional projects, while setting and continually 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. Liaise with stakeholders on an ongoing basis and identify possible interactions with other projects / operations.

User Project Lead (see Sanofi's PUMA methodology)

  • Responsible for defining user requirements,

  • organizing training, ensuring acceptance and deployment of the solution from a user perspective

  • May represent the System Owner during the project

  • Coordinates and manages all user activities

Business Process

  • Ensure the business process learns from the past, takes in industry trends, and maximizing technology to deliver an industry leading capability.

  • Define User Process Monitoring for the capability including escalation and resolution paths in partnership with the Process Owners.

  • Define Business Continuity plans in conjunction with the Business Process owner, ITS and other stakeholders

  • Prioritize requirements and make recommendations on what should be put into a future release based on highest business value

  • Champion innovation and challenge 'that is the way it has always been done' approaches

  • Partner with the Business Process owner and other stakeholders in the design, authoring, maintenance of Quality Documents

Training & Change Management

  • Partner with the Regulatory Training and Development team to define the global training approach, materials, and delivery

  • Develop global cross functional stakeholder engagement strategies

  • Develop, review and approve change strategy, approach, communication plan, and materials.

  • Support change engagement sessions (including leadership engagement sessions)

  • Review and approve at the project level communication/ engagement deliverables

  • Define and maintain User Access request process set up

  • Design and create End User system Training course content

  • Create/maintain performance support materials - content of job aids

  • Coordinate Super User Network


  • 10-15 experience, with experience in the pharmaceutical industry specifically enabling regulatory processes with data and technology.

  • Prior demonstrated experience leading process and technology projects in Regulatory.

  • Experience with Publishing global dossiers

  • Demonstrated ability to establish effective working relationships in different functions.

  • Strong organization and communication skills within a matrixed organization

  • Demonstrated ability to effectively influence leaders and team members.

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.

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Principal Capability Professional For Regulatory End-To-End Processes, Regulatory Intelligence And Adprom Capabilities

Principia Biopharma Inc.