Solutioning Lead – Regulatory Affairs (Pre-Sales & Solutioning)
Position Overview We are seeking a dynamic, strategic, and domain-focused Solutioning Lead to join our Pre-Sales and Solutioning team. This role is central to our growth engine, driving the end-to-end development of compelling, innovative, and compliant service models for global clients.
The focus will be primarily on Medical Product Regulatory (MPR) affairs-spanning pharmaceuticals, medical devices, and combination products. The role owns the response strategy for RFIs and RFPs, translating complex client challenges into scalable, tech-enabled regulatory service models.
Key Responsibilities
- RFI/RFP Ownership: Lead the end-to-end solution engineering for RFIs and RFPs, defining the delivery model, scoping, resource estimation, and commercial frameworks.
- MPR Domain Strategy: Design robust solutions tailored to Medical Product Regulatory (MPR) requirements, including global regulatory submissions, labeling, CMC, strategy, and compliance.
- Value Proposition Crafting: Collaborate with commercial and delivery leadership to articulate clear, differentiated value propositions that blend domain expertise with digital transformation.
- Cross-Functional Collaboration: Act as the central anchor between Sales, Delivery, and Finance teams to ensure technical proposals are operationally viable and commercially sound.
- Client Presentations: Confidently present technical solutions and delivery models to prospective client stakeholders during solution defense meetings.
Qualifications & Experience
- Experience: 8–12 years of overall experience in the Life Sciences/Regulatory Affairs domain, with a strong background in Pre-Sales, Bid Management, or Solutioning.
- Domain Knowledge: Deep understanding of the global Medical Product Regulatory (MPR) landscape and health authority guidelines.
- Analytical Skills: Strong capability in financial modeling, pricing strategies, and effort estimation/gridding for large-scale delivery models.
- Communication: Exceptional written and verbal communication skills, with a proven track record of writing high-quality executive summaries and technical proposals.
