Regulatory Affairs Assistant – Healthcare
Scienta · Paris et périphérie
Description du poste
About the role
The Regulatory Affairs Assistant will support the regulatory team of an international healthcare organisation, helping to prepare and submit product registrations, renewals and variations across multiple markets. Working in a collaborative, fast‑paced environment, the role ensures compliance with international regulatory standards and assists cross‑functional teams throughout the product lifecycle.
Key responsibilities
- Prepare and compile administrative documentation for regulatory submissions, including registrations, renewals and variations.
- Coordinate dispatch and tracking of regulatory dossiers and product samples with local health authorities and external partners.
- Manage certification, legalisation and translation processes for regulatory documents.
- Support departmental administrative activities such as purchase orders and invoice management.
- Maintain electronic regulatory archives and databases to ensure traceability and compliance with internal quality standards.
- Collaborate with internal stakeholders – Regulatory Affairs, Quality, Pharmacovigilance, R&D and Marketing – to support regulatory compliance and continuous process improvement.
Required profile
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences or a related scientific discipline.
- Strong organisational skills with the ability to manage multiple deadlines in a highly regulated environment.
- Fluent English communication skills (minimum B2 level).
- Previous industry or regulatory experience is advantageous but not mandatory.
Required skills
- Proficiency in Microsoft Office applications.
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Scienta
Paris et périphérie
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