Senior Expert Regulatory Affairs – Immunological Products

Position Context
As part of its global development strategy for vaccines and immunological products, Ceva is strengthening its regulatory expertise at corporate level.
The Senior Expert Regulatory Affairs – Immunological Products acts as a senior regulatory reference for a portfolio of biological products, working closely with R&D, Quality, Manufacturing, and Business teams.
The position is part of Corporate / Global Regulatory Affairs and operates in a complex, international, matrix organization.
Key Missions
Define and drive global regulatory strategies for immunological products.
Actively contribute to strategic development and portfolio prioritization decisions.
Serve as a business partner and exercise strong cross‑functional influence across the organization.
Lead regulatory advocacy activities and regulatory intelligence, including active participation in trade associations, monitoring of regulatory trends, and anticipation of regulatory changes
Lead strategic interactions with Health Authorities
Key Responsibilities
Product Development & Lifecycle Management
Drive regulatory input across product development and lifecycle, including definition of regulatory strategies, risk assessment, and contribution to product roadmaps and long‑term lifecycle plans.
Assess regulatory risks and impacts on time‑to‑market, costs, and market opportunities, providing clear, risk‑based input to go / no‑go decisions.
Advise Research teams on innovative technologies or modalities with undefined regulatory pathways, shaping early regulatory strategies to enable development and future market access.
Lead or oversee the preparation, review, and submission of regulatory dossiers (MAAs, extensions, complex variations), ensuring scientific quality and continuous regulatory compliance.
Business Partnership & Cross‑Functional Influence
Act as a strategic business partner to Marketing, Business Development, Portfolio Management, Supply, and R&D teams.
Translate regulatory constraints into clear, actionable insights for non‑regulatory stakeholders.
Influence decisions without direct line management in a matrix environment.
Serve as a senior regulatory reference and escalation point on critical topics.
Regulatory Advocacy & Trade Associations
Represent Ceva within relevant trade associations, industry working groups, and professional bodies.
Contribute to industry positions and proactively support Ceva’s regulatory interests in an ethical manner.
Participate in public consultations and industry initiatives related to immunological products.
Strengthen Ceva’s external visibility and credibility within the regulatory ecosystem.
Regulatory Intelligence & Monitoring
Conduct structured regulatory monitoring of legislation, guidelines, and global regulatory trends.
Assess potential impacts on development programs, portfolio strategy, and commercial plans.
Communicate insights in a concise, decision‑oriented manner to internal stakeholders.
Proactively propose mitigation or anticipation actions to turn regulatory constraints into strategic opportunities.
Health Authority Interactions
Act as the senior regulatory interface with Health Authorities for immunological products.
Lead and contribute to scientific advice, pre‑submission meetings and key regulatory discussions.
Ensure consistent, clear regulatory positions aligned with Ceva’s strategy and business objectives.
Mentoring
Provide mentoring and scientific/regulatory guidance to less experienced Regulatory Affairs team members, contributing to capability building, knowledge sharing, and overall regulatory excellence.