Interim Regulatory Affairs · Pharma · WRPA, Germany
Interim Regulatory Affairs Manager for pharmaceutical companies
Temporary coverage of an RA role or supplement to an existing function — flexibly scaled from short-notice capacity bridging up to full role coverage, combined with programme leadership from a single source.
Whether as interim manager for marketing authorisations, as a freelance Regulatory Affairs Manager bridging a capacity gap, or as programme lead for a lifecycle project: I work independently, on a day-rate basis and with a clearly defined mandate.
Interim RA Management
Variations, renewals, PSUSA procedures and outcome implementation, health authority liaison and dossier maintenance — including national implementation of centralised procedures: product information, packaging and artwork.
Interim Program & Project Leadership
Leadership of lifecycle management and portfolio programs in which regulatory hard gates — regulatory trial clearance, manufacturing planned in parallel with the regulatory pathway — are built into the timeline from day one as fixed constraints.
EU Reform Readiness
Time-boxed mandates to implement the new Variations Guidelines and the EU pharmaceutical reform into existing RA processes — typically kicked off by the Diagnostic Sprint, continued seamlessly into a mandate where needed.
Diagnostic Sprint
Two-week fixed-price sprint (EUR 5,000) for up to 5 products and up to 3 markets: variations, eCTD and reform exposure check, risk-weighted gap register and 90-day action plan with live readout session.
The gap
Coordinating two experts costs time. One person who can do both doesn't.
Whether it's the local affiliate of a global group or a mid-size pharmaceutical company: regulatory projects lose time because RA expertise and program leadership sit with two different external experts who first have to align with each other. In practice, RA is often the point where Manufacturing, Pharmacovigilance, Commercial and Legal timelines already converge — left uncoordinated, that exact node becomes the program's bottleneck.
–Depth without leadership
Regulatory substance is there — coordinating the overall program, timeline control and cross-functional governance remain with the client or a second external role.
–Leadership without RA coverage
Program management is there — regulatory decisions, health authority correspondence and content assessment still require an additional RA specialist.
✓Both in one person
Regulatory governance and program leadership from a single source — no ramp-up time into the other discipline, and no handoff loss between two external roles.
Working together
How a mandate starts.
- 01Initial conversationA short conversation on scope, timeline and required capacity — remote or on site.
- 02Mandate scopingClear scoping: a pure RA role, pure program leadership, or a combined mandate.
- 03Start without ramp-upImmediate operational capability in both disciplines — no onboarding of a second external role required.
- 04Ongoing governanceRegular reporting, stage-gate decisions and transparent escalation.
Terms.
Mandates are delivered remotely, on site or in a hybrid model — depending on the client's needs. The day rate depends on mandate type and the contractually agreed engagement duration.
Solution-focused
If a variation stalls on a national requirement, you don't just get a description of the problem — you get two or three concrete paths forward, each with effort and risk attached.
Proactive
A RAID log runs from day one — not just once a milestone starts to slip. Blockers arrive as early warnings, not as surprises in the status meeting.
Transparent
A status showing "green" when it's actually "amber" helps no one. You get the real picture — even when it's uncomfortable.
Pragmatic
The theoretically cleanest process is of little use if it can't be implemented within the available time frame. Decisions are shaped by the actual resource constraints, not the textbook.
Next step
Available at short notice for mandates across the EU.
Freelance and interim mandates available now – remote, hybrid or on site in the Frankfurt Rhine-Main region.
Tell me briefly about your project — or book a 30-minute call directly.