Senior Regulatory Affairs Specialist

Freyr Solutions; France; Sur place; EUR 50 000 - 90 000; Plein temps

Résumé du poste

An innovative company is seeking a Senior Regulatory Affairs Specialist to join their dynamic team in France. This role offers the opportunity to develop global regulatory strategies and collaborate with multidisciplinary teams to navigate complex compliance requirements. With a focus on excellence, you will play a key role in supporting the lifecycle management of regulatory submissions and ensuring adherence to industry standards. If you are passionate about making a real impact in the Life Sciences sector and thrive in a collaborative environment, this position is perfect for you. Join us in redefining regulatory excellence!

Qualifications

• 5-8 Jahre Erfahrung in Regulatory Affairs mit Schwerpunkt auf EU CTR und CTIS.
• Kenntnisse in der Einreichung von regulatorischen Anwendungen über Health Authority Portale.

Responsabilités

• Entwicklung globaler regulatorischer Strategien und Planung von Einreichungen.
• Zusammenarbeit mit dem globalen regulatorischen Team zur Erfüllung von Verpflichtungen.

Connaissances

EU CTR

CTIS

CTA experience in Medicinal Products

Attention to detail

Document Management Systems

Microsoft Office Suite

SharePoint

Outils

Documentum

Description du poste

Not for Candidates located in India Applications from locations other than France / EU / UK will not be considered.

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. We are committed to excellence and innovation, assisting pharmaceutical, medical device, and biotech companies in navigating regulatory compliance complexities.

Why Freyr?

At Freyr, we foster a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand, we seek passionate and skilled Regulatory professionals to shape the future of regulatory services.

Join Our Team

If you're ready for growth and innovation, connect with us to explore exciting opportunities at Freyr. Together, we can redefine regulatory excellence.

To Apply

Please apply to this job post or visit our Careers page for more openings. Explore current job openings and submit your application. Don't miss the chance to be part of Freyr's expansion and make your mark in regulatory services.

Position Details

• Title: Senior Regulatory Affairs Specialist
• Location: France / EU / UK
• Experience: 5 to 8 years in Regulatory Affairs
• Key Skills: Hands-on EU CTR, CTIS, CTA experience in Medicinal Products

Job Description

1. Provide critical support in developing global regulatory strategies, planning, and execution of investigational submissions, managing lifecycle activities in collaboration with the Global Regulatory Lead (GRL).
2. Collaborate with the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations) to contribute to regulatory plans, address issues, and fulfill obligations.
3. Research and apply regulatory intelligence to navigate complex requirements and develop innovative pathways.
4. Perform independent QC on CTA submissions, including documents and data within CTIS and IRAS portals.
5. Coordinate CTA activities with multidisciplinary teams as a liaison.
6. Support preparation, submission, lifecycle management, and archiving of CTA submissions and correspondences.
7. Develop regulatory operations work instructions as needed.
8. Stay updated with regulatory and industry standards.

Required Competencies

• Knowledge of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) Regulations 2019.
• Experience managing and producing time-sensitive deliverables.
• Attention to detail in data entry and process adherence.
• Knowledge of Document Management Systems (preferably Documentum).
• Experience submitting regulatory applications via Health Authority Portals.
• Proficiency in Microsoft Office Suite and SharePoint.
• Experience with regulatory applications such as CTAs is preferred.