Interim Regulatory Program Lead · Pharma
Regulatory affairs meets
certified project management.
Interim Regulatory Affairs Manager and program lead for marketing authorizations and R&D projects.
I support Regulatory Affairs and program teams at international pharmaceutical companies — from local affiliates to global portfolio programs — with additional, immediately operational capacity when acute or expanding needs arise, such as those driven by the EU pharmaceutical reform.
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.
Services
Four engagement types, one skill profile.
Mandates range from a pure specialist role to combined governance and leadership responsibility for an entire program — complemented by a standalone, fixed-price diagnostic sprint for a no-commitment first step. For companies mid-transition to eCTD v4.0, a companion project-coordination service is available (more here).
Interim RA Management
Temporary coverage of an RA role: variations, renewals, PSUSA procedures and outcome implementation, health authority liaison and dossier maintenance — flexibly scaled from short-notice capacity bridging up to full role coverage.
Interim Program & Project Leadership
Leadership of lifecycle management and portfolio programs in which regulatory hard gates — regulatory trial clearance (e.g. CTA in the EU), manufacturing planned in parallel with the regulatory pathway — are built into the timeline from day one as fixed constraints, not reconciled after the fact between separate RA and PM roles.
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 (below), continued seamlessly into a mandate where needed.
Regulatory & Program Readiness Diagnostic Sprint
A fixed-price, two-week sprint for a bounded portfolio slice (up to 5 products, up to 3 markets): a variation, eCTD, and reform exposure check, a risk-ranked gap register, and a 90-day action plan, closed out with a live readout.
EUR 5,000 fixed feeMore topics: Regulatory Affairs Consultant Frankfurt / Rhine-Main · Marketing Authorisation Renewal · Regulatory Due Diligence & MA Transfer · eCTD v4.0 Transition · EU Variation Classification Tool
Diagnostic sprint
A fixed-price sprint, not an open-ended audit.
A two-week engagement bounded to a defined portfolio slice: a variation, eCTD, and reform exposure check against your actual data, prioritized and turned into a 90-day action plan.
Agree the scope
Up to 5 products, up to 3 markets — agreed together on the kickoff call.
Exposure check
A variation, eCTD, and reform exposure check run against your actual data.
Risk ranking
Rank every finding by risk and timeline impact; build the 90-day action plan.
Live session
Presenting the findings and answering questions together.
- ✓Executive risk-ranked summary (1 page)
- ✓Detailed gap register, each finding traced to its regulatory source
- ✓90-day action plan with a critical-path view
- ✓Live readout session (90 minutes)
Optional continuation: findings can flow directly into an EU Reform Readiness Mandate, billed at day rate — plus 6 months of complimentary, portfolio-specific Reform & Guideline Radar monitoring for Sprint and mandate clients.
The Navigator is the free classification tool showing the same methodology behind the Sprint — including a report download for your own records.
Track record
Twenty years of practice — performance rated 'with fullest recognition' in my reference letter.
“I combine nine years of Regulatory Affairs experience across more than a hundred markets with eight years of project and program leadership, PMP-certified since 2024.”
Julius Vincenz Weidlich, PMP · most recently Senior Project Manager – Program Management, Viatris (MEDA Pharma GmbH & Co. KG), 2017–2025In-house role in a global group — not an external consultant
This experience was gained within the in-house RA and program organization of Viatris (MEDA Pharma), not as an external advisor.
Case studies
Five project types, by example.
Five projects from my time at Viatris.
← Scroll sideways →
Challenge
Objectives
Approach
Results
Lessons
Why it matters
EU pharmaceutical reform 2026–2028
The regulatory timeline that mandates are shaped around.
The biggest overhaul of EU pharmaceutical law in over 20 years is creating concrete, dated adjustment needs inside RA departments. Two separate, parallel-running procedures should be distinguished: the revision of the Variations Guidelines (already in force) and the adoption of the new EU pharmaceutical legislation itself (still in the legislative process).
Political trilogue agreement
Council, Parliament and Commission agree on the reform of EU pharmaceutical law.
New Variations Guidelines take effect
The revised guidelines replace the 2013 version and change variations processes immediately — independent of the legislative procedure for the new pharmaceutical law.
Formal adoption
Council: positions formally adopted on 28 September 2026. Parliament: acceptance without amendments at second reading recommended, plenary vote indicatively on 23 November 2026.
24-month transition period
Enters into force 20 days after publication in the Official Journal; general application 24 months later — expected late 2028 to early 2029. Individual provisions apply earlier or later.
↺ Click the timeline to replay the animation
Career
Twenty years, two disciplines, one regulatory process.
Independent interim manager since 2026 — backed by twenty years of continuous internal ownership of exactly the responsibilities now in focus.
Earlier positions 2000–2009
Scientific-technical foundation
No university degree in a natural science — instead, MTLA training as the scientific-technical foundation, plus twenty years of Regulatory Affairs and project-leadership practice across more than 100 markets. That's why I deliberately exclude purely science-driven RA roles such as toxicology from my service scope.
Working together How a mandate starts.
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 that shows 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 worth little if it doesn't fit the available time window. Decisions are shaped by the actual resource constraints, not the textbook.
Contact
Let's start a conversation.
Available on short notice for mandates across DACH and the EU. Tell me a bit about your project.
Reply typically within one business day — no commitment required.
If you'd rather write or call directly — contact details below.