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Hellowork a estimé le salaire pour cette offre

Cette estimation de salaire pour le poste de Regulatory Affairs Officer H/F à Paris est calculée grâce à des offres similaires et aux données de l’INSEE.

Cette fourchette est variable selon expérience.

Salaire brut min

42 500 € / an 3 542 € / mois 23,35 € / heure

Salaire brut estimé

51 200 € / an 4 267 € / mois 28,13 € / heure

Salaire brut max

65 000 € / an 5 417 € / mois 35,71 € / heure

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Regulatory Affairs Officer H/F Excelya

Paris - 75
CDI
Bac +5
Industrie Pharmaceutique • Biotechn. • Chimie
Exp. 1 an min.

Lire dans l'app

Les missions du poste

About the Job

Join Excelya, whereAudacity, Care, and Energydefine who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team within Regulatory Affairs. You will play a key part in ensuring compliance, supporting regulatory strategies, and enabling the successful development and maintenance of innovative health products. You'll evolve in a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

- 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, postapproval).
- 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.

Le profil recherché

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

- 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 postmarketing).
- Ability to interpret regulations and provide clear guidance to operational teams.

- Education: Bachelor's degree in life sciences, pharmacy, or a related scientific discipline (or equivalent qualification).
- Languages: Fluent in French and English (written and spoken).

Bienvenue chez Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

Publiée le 19/01/2026 - Réf : c7b69f9e-85a1-4e37-b35c-33d7c7411a4d