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Team Manager - Regulatory Affairs Procedures, Europe Zone - Job Opportunity at Ceva Tiergesundheit GmbH

Libourne, France

Full-time

Senior

Posted: July 3, 2025

On-site

EUR 85,000 - 115,000 per year based on the senior management level, specialized regulatory expertise required, team leadership responsibilities, and the role's strategic importance in a global pharmaceutical company operating in the high-growth animal health sector

Benefits

Opportunity to work for a global leader in animal health with significant market presence and growth potential

Exposure to cutting-edge biotech product development and regulatory innovation in veterinary pharmaceuticals

Leadership development through direct management of a 4-person specialized team

Professional growth through participation in trade association working groups and regulatory authority interactions

Digital transformation involvement providing experience with emerging regulatory technologies

Cross-functional collaboration with R&D, Marketing, and Operations teams enhancing career versatility

International exposure through European zone coverage and potential International zone responsibilities

Key Responsibilities

Drive strategic regulatory portfolio management across European markets to ensure competitive positioning and market access for Ceva's pharmaceutical products, directly impacting revenue generation and market expansion

Lead cross-functional collaboration with R&D, Marketing, and Operations teams to align regulatory strategy with business objectives and accelerate product development timelines

Serve as primary regulatory liaison with European authorities, building critical relationships that facilitate faster approvals and regulatory compliance

Develop and execute comprehensive registration and maintenance programs that protect and expand Ceva's market presence across multiple European jurisdictions

Manage and mentor a team of 4 regulatory professionals, building departmental capabilities and ensuring succession planning for critical regulatory functions

Champion digital transformation initiatives within the regulatory department, positioning the organization for future operational excellence and competitive advantage

Represent Ceva in industry working groups and regulatory forums, enhancing company reputation and staying ahead of regulatory trends that impact business strategy

Requirements

Education

Degree in Pharmacy or Veterinary Regulatory Affairs or equivalent in the field of Chemistry, Pharmacy and/or Regulatory Affairs

Experience

At least 7 years' experience in veterinary drug registrations with experience in Biotech product development

Required Skills

Solid strategic and technical knowledge of regulatory affairs, with a global and long-term vision Experience in leading major submissions (e.g. EMA, USFDA) is a plus Ability to manage and coordinate complex projects Ability to negotiate effectively with different types of interlocutors, including the authorities Ability to manage stressful situations with internal and external stakeholders Promoting new regulatory initiatives internally Demonstrate exemplary leadership and ensure ethics and transparency within the department Master the art of scientific language in English (both oral and written) Organised and rigorous Be solution and customer oriented

Sauge AI Market Intelligence

Industry Trends

The animal health industry is experiencing unprecedented growth driven by increasing pet ownership, rising demand for animal protein globally, and growing awareness of zoonotic diseases following the COVID-19 pandemic. This trend is creating substantial opportunities for regulatory professionals who can navigate complex approval processes across multiple jurisdictions. Regulatory harmonization efforts across European markets are creating demand for professionals who can manage multi-country registration strategies efficiently. The European Medicines Agency's centralized procedures and mutual recognition pathways are becoming increasingly important for market access optimization. Digital transformation in regulatory affairs is accelerating with electronic submissions, AI-powered data analysis, and digital regulatory intelligence platforms becoming standard practice. Companies are seeking regulatory leaders who can drive these technological adoptions while maintaining compliance excellence. The One Health approach is gaining significant traction in veterinary pharmaceuticals, with regulatory agencies increasingly focused on the interconnection between animal, human, and environmental health. This shift is creating new regulatory pathways and requirements that demand sophisticated strategic thinking.

Role Significance

Direct management of 4 regulatory professionals with likely indirect influence over additional cross-functional team members across R&D, Marketing, and Operations. The role involves coordination with multiple international teams and external stakeholders including regulatory authorities and trade associations

This is a senior management position with significant strategic responsibility, evidenced by the requirement for 7+ years of experience, team leadership responsibilities, direct interaction with regulatory authorities, and the role's positioning as a key liaison between R&D, Marketing, and Operations functions within a global pharmaceutical organization

Key Projects

Leading European market access strategies for novel biotech veterinary products requiring complex regulatory pathways and innovative approval approaches Managing major regulatory submissions to EMA and national authorities for high-value pharmaceutical products with multi-million dollar market potential Implementing digital transformation initiatives to modernize regulatory processes and enhance operational efficiency across European operations Developing regulatory defense strategies for existing product portfolios to maintain market exclusivity and competitive positioning

Success Factors

Deep understanding of European regulatory landscape combined with global pharmaceutical development experience enables effective navigation of complex multi-jurisdictional approval processes and strategic market access planning Strong leadership and team development capabilities are essential for building regulatory expertise within the organization and ensuring successful execution of complex regulatory strategies across multiple product lines Exceptional stakeholder management skills are critical for maintaining productive relationships with regulatory authorities, internal cross-functional teams, and external partners while managing competing priorities and tight deadlines Strategic thinking ability to align regulatory activities with business objectives and identify opportunities for competitive advantage through regulatory innovation and market access optimization

Market Demand

High demand driven by the critical nature of regulatory expertise in pharmaceutical market access, the specialized knowledge required for veterinary drug approvals, and the shortage of experienced regulatory professionals with both technical expertise and leadership capabilities in the European market

Important Skills

Critical Skills

Strategic regulatory affairs knowledge is absolutely essential as this role requires making complex decisions about multi-jurisdictional approval strategies that directly impact product launch timelines and market access success. The ability to think strategically about regulatory pathways can mean the difference between successful market entry and costly delays or rejections. Leadership and team management capabilities are critical for success given the direct management of 4 professionals and the need to coordinate complex cross-functional initiatives. The ability to develop talent and build organizational capabilities will determine long-term departmental success and personal career advancement. Authority negotiation skills are vital as the role involves direct interaction with regulatory agencies across multiple European countries. The ability to build productive relationships with regulators and effectively advocate for product approvals is essential for achieving business objectives and maintaining competitive advantage.

Beneficial Skills

Experience with major regulatory submissions (EMA, FDA) would significantly enhance effectiveness in this role as it provides credibility with both internal stakeholders and external authorities while enabling more sophisticated regulatory strategy development Digital transformation experience is increasingly valuable as the industry moves toward electronic submissions, AI-powered regulatory intelligence, and digital process optimization. This expertise will become essential for maintaining operational efficiency and competitive positioning Biotech product development experience is particularly beneficial given the industry's shift toward innovative biological products and the complexity of regulatory pathways for these advanced therapeutic approaches

Unique Aspects

This role offers rare exposure to both traditional pharmaceutical regulatory affairs and emerging biotech product development, providing comprehensive experience across the full spectrum of veterinary medicine innovation

The position combines strategic regulatory leadership with hands-on authority interaction, offering direct influence on product approvals and market access decisions that impact company revenue and growth

The digital transformation component provides cutting-edge experience with regulatory technology adoption, positioning the role holder at the forefront of industry innovation

The One Health approach integration offers exposure to emerging regulatory paradigms that will shape the future of veterinary pharmaceutical development

Career Growth

Progression to next level roles typically occurs within 3-5 years given the strategic nature of the current position and the accelerating growth in the animal health sector

Potential Next Roles

Head of Regulatory Affairs for larger geographic regions or global responsibilities within multinational pharmaceutical companies Vice President of Regulatory Affairs and Quality Assurance with expanded portfolio management and strategic planning responsibilities Chief Regulatory Officer positions in mid-size pharmaceutical or biotech companies with full regulatory strategy ownership Senior regulatory consulting roles with top-tier consulting firms serving pharmaceutical industry clients

Company Overview

Ceva Tiergesundheit GmbH

Ceva Animal Health is a global leader in animal health solutions with a strong presence in veterinary pharmaceuticals, vaccines, and health management products. The company has established itself as a significant player in the animal health market through strategic acquisitions, innovative product development, and global expansion initiatives across multiple therapeutic areas

Ceva holds a strong position in the global animal health market, ranking among the top 10 animal health companies worldwide with particular strength in livestock and companion animal segments. The company's focus on innovation and geographic expansion has positioned it as a key competitor to industry leaders like Zoetis, Merck, and Boehringer Ingelheim

The Libourne location represents Ceva's European headquarters operations, positioning this role at the center of the company's European regulatory strategy. This location provides direct access to key European markets and regulatory authorities, making it strategically important for driving market access across the region

Ceva's "Together, Beyond Animal Health" vision and One Health approach suggest a collaborative, purpose-driven culture focused on innovation and cross-functional teamwork. The company's emphasis on passionate people and global partnership indicates a supportive environment for professional development and career growth

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Team Manager - Regulatory Affairs Procedures, Europe Zone - Job Opportunity at Ceva Tiergesundheit GmbH

Benefits

Key Responsibilities

Requirements

Education

Experience

Required Skills

Sauge AI Market Intelligence

Industry Trends

Role Significance

Key Projects

Success Factors

Market Demand

Important Skills

Critical Skills

Beneficial Skills

Unique Aspects

Career Growth

Potential Next Roles

Company Overview

Ceva Tiergesundheit GmbH

Data Sources & Analysis Information

Job Listings Data

Sauge AI Market Intelligence