Design and Implementation of a Target Operating Model and Use Case Pipeline for a Regulatory Affairs Digital Transformation Initiative in the Life Sciences Industry

Daily rate

By arrangement

Expenses

plus expenses

Project duration

as of now - 31.01.2026

Deployment country

Germany

Deployment city

Not published

Required availability

100 %

Industry

Pharmaceuticals & medical technology

Function

Legal & Compliance

Service

Project management

Our client, an international life sciences company, is seeking an experienced Consultant Digital Transformation – Regulatory Affairs (m/f/d) ad interim to design and implement a Target Operating Model (TOM), define an intake and prioritization framework for the newly formed regulatory digital systems team, and build a qualified pipeline of digital use cases focusing on CMC and non‑EU submissions. The initial engagement aims to establish governance, a pragmatic intake mechanism, and a transparent, value-driven prioritization model while delivering a demonstrator to create early momentum.

Main Tasks:

• Design and implement the Target Operating Model (TOM) and establish governance cadences for the digital systems team
  
• Develop and launch a lightweight intake and prioritization framework using Microsoft Power Apps and SharePoint
  
• Identify, qualify, and size digital use cases in Regulatory Affairs with a focus on CMC and non‑EU submissions
  
• Define transparent prioritization rubrics based on cycle-time reduction, efficiency gain, and business impact
  
• Collaborate closely with the Head of Digital Systems, business stakeholders, and SMEs to align priorities and secure sponsorship
  
• Build one thin-slice demonstrator using Microsoft Power Platform and AI-based tools to showcase initial results
  
• Ensure smooth handover and knowledge transfer to the internal digital systems team
  

Personnel accountability

Not specified

Budget accountability

Not specified

• Strong experience in digital transformation within the life sciences industry, including substantial exposure to Regulatory Affairs (CMC and submissions)
  
• Proven track record in designing and launching Target Operating Models, intake, and governance frameworks for RPA/AI or digital teams
  
• Hands-on expertise with Microsoft Power Platform (Power Apps, Power Automate, SharePoint) and document-centric AI
  
• Demonstrated ability to identify, qualify, and prioritize digital use cases, quantify business value, and establish pragmatic delivery cadences within short timelines (e.g. 12 weeks)
  
• Fluency in English; additional languages are a plus
  

Linguistic proficiency