PROFILEPharmaceutical companies looking for a more efficient use of time and resources on regulatory projects benefit from combining Regulatory Affairs expertise and program leadership in a single, accountable role ? rather than coordinating two separate external specialists. I provide exactly that. As an Interim Regulatory Affairs & Program Manager with 20+ years in the pharmaceutical industry, I combine 9 years of hands-on Regulatory Affairs experience across 100+ markets with 8 years of PMP-certified project and program leadership. At Viatris, I led a portfolio of approximately 20 parallel Lifecycle Management programs across cross-functional teams of 10?25, accelerating project timelines by 10?20%. Available on short notice for interim mandates ? particularly relevant as the EU Pharmaceutical Reform reshapes regulatory processes from 2026 onward.
CORE COMPETENCIES- Interim Regulatory Affairs Management
- Interim Program & Project Leadership
- MAA Submission Support
- Variations & Renewals (MRP, DCP, CP, NP)
- Lifecycle Management (LCM)
- CMC Project Leadership
- Regulatory Strategy
- CTD/eCTD
- Cross-Functional Leadership
- Stage-Gate Governance
- RAID & Critical Path Management
- Portfolio Prioritization
- Budget Planning
- Stakeholder Engagement
- Change Control
- GxP/GMP Awareness
- Business Case Development
PROFESSIONAL DEVELOPMENT- Continuously updated skills through professional certifications and training programs.
- Actively participated in industry conferences and workshops to stay abreast of the latest trends and best practices in project management and pharmaceutical regulations.
SKILLS- Software:
- MS Office
- MS Project
- OnePager (Gantt Tool)
- MTLA Skills:
- Proficient in laboratory techniques including microbiology, clinical chemistry, hematology and immunology.
- Experienced in operating laboratory equipment and conducting diagnostic tests.
- Knowledgeable in quality control and laboratory safety protocols.