Regulatory Affairs Specialist

Freyr Solutions; Lyon; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in regulatory solutions seeks a Regulatory Affairs Specialist to manage compliance with French regulations. This role involves preparing submissions, localizing documents, and ensuring audit readiness. Ideal candidates have 5+ years in regulatory affairs and fluency in French procedures.

Qualifications

• 5+ years in Medicinal Products Regulatory Affairs.
• Fluency in French regulatory procedures.

Responsabilités

• Manage end-to-end regulatory submissions aligned with the French Medicines Agency (ANSM).
• Compile and validate Product Information in French.

Connaissances

Proficiency in CESP

Proficiency in EMA IRIS

Proficiency in XEVMPD

eCTD publishing

Multilingual packaging management

Regulatory compliance

Description du poste

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team :

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

To Apply :

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https : / / www.freyrsolutions.com / careers / current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title : Regulatory Affairs Specialist / Local Regulatory Consultant

Location : France

Experience : 5+ years in Medicinal Products Regulatory Affairs.

Reporting To : Regional Regulatory Lead

Position Summary :

The Local Regulatory Consultant – France will manage end-to-end regulatory submissions and lifecycle maintenance in close alignment with the French Medicines Agency (ANSM). The role requires fluency in French regulatory procedures, especially within the context of EU frameworks, while ensuring national compliance in labelling, submission timelines, and product lifecycle governance. Operating within a digital-first regulatory environment, the consultant will drive compliant market access and support post-authorization activities effectively.

Key Responsibilities :

• Prepare and submit Centralized (CP), Decentralized (DCP), Mutual Recognition (MRP), and national applications, including initial marketing authorizations, renewals, variations, and notifications in accordance with local requirements.
• Compile and localize Module 1 documentation, including French Blue Box content, statutory documents, and mock-ups.
• Adapt and validate Product Information (PI) including PILs, SmPCs, and labelling in French, aligned with EU QRD templates and ANSM guidelines.
• Ensure multilingual packaging compliance, with a focus on French and English, maintaining alignment with local and regional labeling strategies.
• Submit applications via CESP, maintain product data in XEVMPD, and track lifecycle milestones using RIMS or equivalent tools.
• Monitor submission timelines, handle ANSM queries, and implement CHMP or CMDh outcomes in a compliant and timely manner.
• Ensure audit readiness through meticulous document archiving, version control, and adherence to EMA and ANMM regulatory record-keeping standards.
• Collaborate closely with cross-functional teams, particularly market access, to support pricing and reimbursement submissions in line with local processes.
• Maintain up-to-date knowledge of local regulatory requirements and ensure readiness for regulatory audits or FIMEA inspections.
• Support regional harmonization efforts across EU countries, contributing to consistent labelling and packaging practices

Technical & Functional Skills :

• Proficiency in CESP, EMA IRIS, XEVMPD, and eCTD publishing tools, aligned with EU and ANSM submission formats.
• Demonstrated experience with ANSM procedures, including national regulatory requirements, lifecycle submissions, and HA correspondence.
• In-depth understanding of EU regulatory frameworks, including centralized, decentralized, and mutual recognition procedures.
• Expertise in multilingual packaging management, especially French and English, including local adaptation and Blue Box compliance.
• Practical experience in applying EU QRD templates for PI localization and approval.
• Familiarity with EU labelling harmonization practices across EU.
• Experience supporting pricing and reimbursement dossiers, with understanding of ANSM’s role in health technology assessments and market access approvals.
• Competence in using RIMS and related systems to manage regulatory timelines, document control, and submission lifecycle tracking.
• Proven ability to support regulatory audits and inspection readiness through accurate documentation, archiving, and regulatory intelligence.