Regulatory Affairs Officer H/F - 75

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.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.