Regulatory Affairs Officer
il y a 14 heures
Join Excelya, where Audacity, Care, and Energy define 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, 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.RequirementsExperience: 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, pharmacy, or a related scientific discipline (or equivalent qualification).Languages: Fluent in French and English (written and spoken).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’s leading mid-size CRO with the best employee experience. Our one-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 care means 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. #J-18808-Ljbffr
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Regulatory Affairs Officer
il y a 4 jours
Paris, Île-de-France Orion Pharma Temps pleinDescriptionAbout your roleWe are looking for a motivated and detail-oriented Regulatory Affairs Officer - Veterinary Medicines to join our team for an 18-month temporary position. In this role you will be responsible for supporting the maintenance of marketing authorizations (MA) in various regions. Your focus will initially be on the EU region, with...
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Regulatory Affairs Senior Manager
il y a 2 semaines
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il y a 13 heures
Paris, France elemed Temps plein🔎 Title: Senior Regulatory Affairs Consultant🔸 The CompanyIf you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company.🔹 As a Regulatory Affairs Consultant your mission is to:Develop and execute...
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il y a 1 semaine
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Remote Regulatory Affairs Specialist – EMEA
il y a 15 heures
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il y a 17 heures
Paris, France Excelya Temps pleinA dynamic health company in Paris is seeking an experienced professional in Regulatory Affairs to ensure compliance and support regulatory strategies for innovative health products. You will prepare regulatory dossiers, ensure documentation compliance, and interface with health authorities. A Bachelor's degree in life sciences or pharmacy is required, along...
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Regulatory Affairs Specialist — Med Devices
il y a 13 heures
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il y a 2 semaines
Paris, Île-de-France Ceva Sante Animale Temps pleinRegulatory Affairs Manager M/FThe success of a company depends on the passionate people we partner with.Together, let's share our talents.As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which...
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il y a 1 jour
Paris, France Qonto Temps plein**Our mission**? Making day-to-day banking easier for SMEs and freelancers thanks to an online business account that's combined with invoicing, bookkeeping and spend management tools. Thanks to its innovative product, highly reactive 24/7 customer support and clear pricing, Qonto has become the leader in its market. **Our journey**: Founded by Alexandre and...
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il y a 1 jour
Paris, France TFS HealthScience Temps pleinTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Regulatory Affairs Project...
