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Regulatory Affairs Associate Promotion and Healthcare Compliance/ Validation - Job Opportunity at Excelya

Lyon, France
Full-time
Entry-level
Posted: July 1, 2025
On-site
EUR 35,000 - 45,000 per year. This estimate reflects entry-level regulatory affairs positions in Lyon, France, considering the candidate's educational requirements and initial experience level. Lyon's cost of living is lower than Paris, but the specialized nature of regulatory affairs work in a growing CRO commands competitive compensation.

Benefits

Opportunity to work in a young, ambitious healthcare company with 900+ employees positioning itself as Europe's leading mid-size CRO
Access to diverse career evolution through one-stop provider service model offering full-service, functional service provider, and consulting opportunities
Collaboration with preeminent experts in clinical research and regulatory affairs
Professional development in an environment that values natural talents and pushes boundaries with audacity
Contribution to meaningful healthcare improvements that directly impact patient journeys
Inclusive work environment fostering both collaboration and individual growth
Stimulating professional environment encouraging personal and intellectual development

Key Responsibilities

Drive strategic compliance oversight for promotional and informational materials targeting healthcare professionals and general public, ensuring market readiness and regulatory alignment
Lead cross-functional collaboration with marketing, medical, and legal teams to establish regulatory frameworks that support business objectives
Maintain adherence to critical regulatory standards including French Loi Bertrand, EFPIA Code, and promotional guidelines, protecting company reputation and market access
Contribute to strategic management of clinical and regulatory projects that directly impact product development timelines and market entry
Coordinate internal stakeholders across clinical, quality, pharmacovigilance, and marketing functions to ensure seamless project execution and delivery
Manage project planning, milestone tracking, and reporting processes that drive operational efficiency and client satisfaction
Monitor contracts, budgets, and deliverables to ensure quality standards and regulatory compliance while optimizing resource allocation
Support vendor audits and continuous improvement initiatives that enhance outsourcing processes and operational excellence
Facilitate preparation and follow-up of regulatory submissions including clinical trial applications and substantial amendments
Conduct regulatory intelligence activities across clinical trials, promotion, ethics, and devices to support strategic decision-making
Develop and update internal procedures and SOPs that standardize operations and ensure consistent compliance across the organization

Requirements

Education

Master's degree (or higher) in Life Sciences, Regulatory Affairs, or Pharmacy

Experience

Initial experience (internship or position) in regulatory or clinical affairs

Required Skills

Knowledge of EU regulations (EU Clinical Trials Regulation 536/2014, GCP, EMA, ANSM) and promotional compliance rules Strong project management and cross-functional collaboration skills Organized, detail-oriented, and a team player Fluent in English (written and spoken)
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Sauge AI Market Intelligence

Industry Trends

The clinical research organization (CRO) market is experiencing significant consolidation with mid-size players like Excelya positioning themselves as alternatives to large multinational CROs, offering more personalized service and faster decision-making capabilities. This trend is driven by pharmaceutical companies seeking more agile partnerships and cost-effective solutions for clinical trials and regulatory services. Regulatory affairs roles are increasingly focusing on promotional compliance and digital content validation as pharmaceutical marketing becomes more sophisticated and digital-first. The integration of traditional regulatory oversight with modern marketing channels requires professionals who can bridge regulatory science with commercial strategy. The European regulatory landscape is becoming more harmonized following Brexit, with increased emphasis on EMA guidelines and EU Clinical Trials Regulation 536/2014 implementation. This creates demand for regulatory professionals who understand both traditional national regulations and new EU-wide frameworks. There is growing emphasis on vendor management and outsourcing optimization in clinical research, as pharmaceutical companies increasingly rely on CROs for specialized regulatory functions. This trend creates opportunities for regulatory professionals with strong project management and vendor oversight capabilities.

Role Significance

Typically part of a 5-8 person regulatory affairs team within a mid-size CRO, working closely with 2-3 senior regulatory professionals and collaborating with cross-functional teams of 10-15 members across clinical, quality, and commercial functions.
This is a junior-to-mid level position that serves as a critical entry point into regulatory affairs with significant growth potential. The role combines tactical execution with strategic input, positioning the candidate as a key contributor to regulatory decision-making processes while building expertise across multiple regulatory domains.

Key Projects

Multi-country clinical trial submissions and amendments requiring coordination across European regulatory agencies Promotional material review campaigns for pharmaceutical product launches involving digital and traditional marketing channels Vendor audit programs ensuring compliance and quality standards across outsourced regulatory functions Regulatory intelligence projects supporting business development and strategic planning initiatives SOP development and harmonization projects standardizing regulatory processes across the organization

Success Factors

Deep understanding of European regulatory frameworks combined with practical application skills in promotional compliance, as the pharmaceutical industry increasingly focuses on compliant marketing strategies that maximize commercial impact while minimizing regulatory risk. Strong cross-functional collaboration abilities that enable effective coordination between regulatory, clinical, marketing, and legal teams, as modern drug development requires seamless integration across multiple disciplines and stakeholder groups. Project management excellence with attention to detail and timeline management, as regulatory affairs professionals must balance multiple concurrent projects while maintaining strict compliance standards and meeting critical submission deadlines. Adaptability to evolving regulatory landscapes and emerging compliance requirements, as the regulatory environment continues to evolve with new guidelines, digital marketing challenges, and post-Brexit regulatory changes. Commercial acumen combined with regulatory expertise, enabling the professional to provide regulatory guidance that supports business objectives while maintaining compliance standards and protecting company interests.

Market Demand

High demand driven by CRO industry growth, increasing regulatory complexity, and the need for specialized promotional compliance expertise in the evolving pharmaceutical marketing landscape.

Important Skills

Critical Skills

EU regulatory expertise (EU CTR 536/2014, GCP, EMA, ANSM) is absolutely essential as it forms the foundation for all regulatory activities and compliance oversight. This knowledge directly impacts the ability to provide accurate guidance and ensure submissions meet regulatory standards. Project management and cross-functional collaboration skills are critical because regulatory affairs work inherently involves coordinating multiple stakeholders, managing complex timelines, and ensuring deliverables meet both regulatory and business requirements. Attention to detail and organizational skills are fundamental to success in regulatory affairs, where small errors can have significant consequences for product approval timelines and regulatory compliance status. English fluency is critical for international regulatory work, as most regulatory submissions, communications with agencies, and client interactions require professional-level English communication skills.

Beneficial Skills

Digital marketing and promotional compliance expertise would be highly valuable as pharmaceutical marketing increasingly moves to digital channels requiring specialized regulatory oversight and compliance strategies. Vendor management and audit experience would enhance value in the CRO environment where outsourcing relationships are critical to service delivery and client satisfaction. Business development acumen would be beneficial for career advancement in the CRO industry, where regulatory professionals with commercial understanding can contribute to client relationship management and business growth. Therapeutic area specialization in high-growth areas such as oncology, rare diseases, or digital therapeutics would provide competitive advantage and enhanced career prospects.

Unique Aspects

This role combines traditional regulatory affairs responsibilities with modern promotional compliance challenges, providing exposure to both clinical development and commercial regulatory aspects that many entry-level positions do not offer.
The position offers direct exposure to vendor management and outsourcing optimization, providing valuable experience in the business side of regulatory affairs that enhances career prospects in the growing CRO industry.
Working within a mid-size CRO environment provides broader exposure to different therapeutic areas and client requirements compared to pharmaceutical company positions, accelerating professional development and industry knowledge.
The role includes regulatory intelligence activities that provide strategic market insights, combining tactical regulatory work with business development support that enhances commercial understanding.
Integration with cross-functional teams across clinical, quality, pharmacovigilance, and marketing provides comprehensive understanding of drug development processes and commercial considerations.

Career Growth

Typically 2-3 years to senior associate level, 4-6 years to management positions, with accelerated progression possible in growing CRO environment where demonstrated expertise and client relationship skills are highly valued.

Potential Next Roles

Senior Regulatory Affairs Associate with expanded responsibilities for complex submissions and team leadership Regulatory Affairs Manager overseeing multiple therapeutic areas or regional markets Clinical Regulatory Affairs Specialist focusing on advanced clinical trial regulatory strategy Regulatory Affairs Consultant providing specialized expertise to multiple pharmaceutical clients Business Development Associate leveraging regulatory expertise to support client acquisition and relationship management

Company Overview

Excelya

Excelya is a rapidly growing European clinical research organization that has positioned itself as a mid-market alternative to large multinational CROs, offering more personalized service and faster decision-making capabilities. With 900 employees, the company represents a significant player in the European CRO market, focusing on full-service clinical development, functional service provision, and regulatory consulting across multiple therapeutic areas.

Excelya occupies a strong position in the European mid-size CRO segment, competing against both large international CROs and smaller specialized service providers. The company's growth trajectory and European focus align well with pharmaceutical industry trends toward regional partnerships and more agile service providers.
Based in Lyon, France, Excelya benefits from access to European regulatory expertise and proximity to EMA and French ANSM regulatory agencies. Lyon's position as a growing biotech hub provides access to both pharmaceutical industry talent and academic research institutions, supporting the company's growth objectives.
The company emphasizes values of Audacity, Care, and Energy, suggesting a dynamic work environment that encourages innovation while maintaining focus on quality and client service. The emphasis on individual growth and collaboration indicates a supportive environment for professional development and career advancement.
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