CRO - Spécialiste des Affaires Réglementaires Clinique - F/H/X

Join Amaris Consulting and support one of our leading clients in managing its regulatory affairs activities.

Responsibilities

Manage the regulatory and legal aspects related to studies and products; Draft, prepare and submit regulatory documents and dossiers to the relevant authorities; Ensure the review and validation of regulatory documentation in line with applicable requirements; Act as the main point of contact for regulatory authorities and manage ongoing interactions; Prepare the documentation required to obtain, renew or update the relevant authorizations and certificates; Ensure that products are manufactured and distributed in compliance with applicable legislation and regulatory requirements; Monitor regulatory renewals and updates throughout the product lifecycle

Requirements

Master's degree in Life Sciences, Regulatory Affairs or a related field, or a degree in Pharmacy; University education or a background in pharmaceutical studies; Good understanding of regulatory requirements and submission processes; Strong organizational skills and the ability to manage several regulatory topics simultaneously; Excellent communication skills and confidence working with different stakeholders

Nice to have

Previous experience in Regulatory Affairs within the pharmaceutical, medical device, cosmetics or another regulated industry would be an advantage

Benefits

Access to our gym club; Lunch vouchers; Free Spanish classes; Possibility to work remotely 2 days per week; An international community bringing together 110+ different nationalities; A robust training system with our internal Academy and 250+ available modules; A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)