Senior Expert Regulatory Affairs – Immunological Products

CEVA Logistics; France; Sur place; EUR 140 000 - 190 000; Plein temps

Résumé du poste

Ceva Animal Health is seeking a Senior Expert Regulatory Affairs - Immunological Products to shape global regulatory strategies across a portfolio of biological products. Based in France, you will collaborate with R&D, Quality, Manufacturing and Marketing to align regulatory plans with business objectives.

You will lead submissions, influence cross-functional teams, mentor colleagues, and represent Ceva in interactions with Health Authorities and trade associations, driving compliance and

Qualifications

• Advanced scientific degree in Pharmacy, Veterinary Medicine, Biology, Biotechnology, or equivalent.
• Minimum 15 years in Regulatory Affairs, ideally in vaccines, biological or immunological products.
• Experience in international and matrix environments.
• Ability to influence strategic decisions beyond the regulatory function.

Responsabilités

• Define and drive global regulatory strategies for immunological products.
• Lead regulatory dossiers submissions (MAAs, extensions, complex variations).
• Mentor Regulatory Affairs team members and build capability.
• Act as senior regulatory reference and escalation point across functions.

Connaissances

Regulatory strategy

Regulatory intelligence

Health authority interactions

Leadership influence

Formation

Advanced scientific degree

Description du poste

Senior Expert Regulatory Affairs - Immunological Products

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Yourmissions :

Position Context

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.

Yourprofile :

Profile

• Advanced scientific degree (Pharmacy, Veterinary Medicine, Biology, Biotechnology, or equivalent).
• Minimum 15 years of experience in Regulatory Affairs, ideally in vaccines, biological or immunological products.
• Strong experience in international and matrix environments.
• Proven ability to influence strategic decisions beyond the regulatory function.

Technical Skills

• Global Regulatory Strategy
• Immunological & Biological Products
• Marketing Authorisation Applications & Lifecycle Management, EU and International
• Variations & Post-Approval Activities
• Regulatory Intelligence & Monitoring
• Regulatory Advocacy & Trade Associations
• Health Authority Interactions

Soft Skills

• Strong business mindset and strategic thinking
• High level of influence and persuasion
• Recognized regulatory expertise and credibility
• Excellent communication skills at senior level
• Assertiveness, diplomacy, and pragmatism
• Autonomy and sound decision-making