Analyst für regulatorische Themen

SymBio. WorkFromHome

Stellenbeschreibung:

Experienced consultant to design and launch the Target Operating Model (TOM), intake, and prioritization framework for the new RAMACA Systems team, and to build a high‑quality pipeline of digital use cases in Regulatory Affairs—prioritizing CMC and non‑EU submissions
Over a focused 3‑month engagement, the consultant will establish governance cadences, implement a lightweight intake mechanism (Power Apps/SharePoint), and define a transparent prioritization rubric centered on cycle‑time reduction and effort saved.
They will conduct rapid discovery with CMC and non‑EU submission SMEs to identify, size, and qualify opportunities, and deliver one thin‑slice demonstrator using Microsoft Power Platform and the AI Platform to create momentum.
The consultant will work closely with the RAMACA Systems team, business stakeholders, and the Head RAMACA Systems to align on priorities, secure sponsorship, and enable a smooth handover.
Emphasis is on TOM and pipeline creation; dashboards and data analysis beyond determining use cases and business cases are out of scope.
CSV familiarity is expected but not the primary focus.

8+ years in life sciences digital transformation with strong exposure to Regulatory Affairs (CMC and submissions), and a proven track record establishing operating models, intake, and governance for RPA/AI teams.
Hands‑on capability with Microsoft Power Platform (Power Automate, Power Apps, SharePoint) and document‑centric AI to run rapid discovery, qualify opportunities, and build thin‑slice demonstrators.
Strong stakeholder management and communication skills; ability to collaborate with RAMACA Systems, business SMEs, and senior sponsors.
Demonstrated ability to quantify benefits (hours saved, cycle time), create prioritization rubrics, and stand up pragmatic delivery cadences within 12 weeks.
CSV familiarity sufficient for fit‑for‑purpose readiness, alignment with IT‑managed AI platforms, and comfort operating within enterprise processes.
Available for a 3‑month engagement with week‑1 access to SharePoint/File Shares and the Submission Management System; ready to engage CMC and non‑EU submission stakeholders immediately.