Regulatory Affairs Job at Excelya | Apply Now
A regulatory affairs job at Excelya offers a unique opportunity for professionals looking to grow in the life sciences sector. With a strong presence in Europe and a commitment to innovation, Excelya provides a collaborative environment where individuals can contribute to regulatory strategies, compliance, and product development. For those exploring excelya careers, this role is ideal for gaining international exposure and advancing in life science jobs in France.
- Job Position: Regulatory Affairs Specialist / Regulatory Affairs Associate
- Location: France
About the Company
Regulatory affairs job opportunities at Excelya provide professionals with a chance to work in a fast-growing and ambitious organization. Excelya is a young health company with a team of over 900 professionals, striving to become Europe’s leading mid-size CRO. Through its one-stop provider service model, the company offers full-service, functional service provider, and consulting solutions.
For candidates interested in excelya careers and jobs in France, the company fosters a culture driven by Audacity, Care, and Energy. Employees work alongside industry experts, contributing to scientific innovation and improving patient outcomes.
Job Description
Regulatory affairs job roles at Excelya involve working within a dynamic Regulatory Affairs team, ensuring compliance and supporting regulatory strategies. This position offers a stimulating environment where professionals can contribute to the development and lifecycle of innovative health products.
The role focuses on maintaining regulatory standards while collaborating with internal teams and external stakeholders. It is an excellent opportunity for individuals seeking impactful life science jobs with global exposure.
Qualifications
Regulatory affairs job candidates must possess the right blend of education, experience, and technical knowledge to succeed in this role.
- Experience: Prior experience or solid knowledge in regulatory affairs within the pharmaceutical, biotech, or medical device sector is essential.
- Skills:
- Understanding of regulatory frameworks and submission processes (EU, EMA, national agencies).
- Familiarity with product lifecycle management (development → registration → post-marketing).
- Ability to interpret regulations and provide clear guidance to operational teams.
- Education: Bachelor’s degree in life sciences or a related scientific discipline (or equivalent qualification).
- Languages: Fluent in French and English (written and spoken).
Key Responsibilities
Regulatory affairs job responsibilities at Excelya include managing regulatory submissions and ensuring compliance with global standards. Key tasks include:
- Prepare, compile, and submit regulatory dossiers (initial submissions, variations, renewals, responses to authorities’ questions).
- Ensure compliance of documentation and activities with applicable regulations (EU, ICH, national authority guidelines).
- Support regulatory strategy throughout product lifecycle (development, registration, post-approval).
- Interface with health authorities, ethics committees, and internal/external stakeholders.
- Track regulatory timelines, approvals, and commitments to ensure smooth project progression.
- Review and validate labeling, artwork, SmPC/PIL, and promotional materials as per regulatory standards.
- Participate in the preparation of audits and inspections related to regulatory aspects.
- Maintain accurate documentation and records in line with internal SOPs and regulatory requirements.
- Identify regulatory risks and propose solutions or mitigation strategies.
Why Join Excelya?
Regulatory affairs job seekers exploring excelya careers will find a supportive and growth-oriented environment. The company emphasizes innovation, teamwork, and employee development.
Employees benefit from:
- Exposure to diverse projects across the healthcare sector
- Collaboration with leading experts in life sciences
- Opportunities for personal and professional growth
- A culture that values talent, innovation, and patient-centric solutions
For professionals searching for life science jobs or jobs in France, Excelya stands out as a company that blends scientific excellence with a strong human focus.
