Regulatory Affairs Manager

About Freyr

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 Manager - EU CTR

Location : United Kingdom

Experience : 5+ years in Medicinal Products Regulatory Affairs with experience in EUCTR / CTIS

Essential duties and responsibilities (included but not limited to the following (Other duties may be

assigned):

• Provide critical support in developing global regulatory strategy, planning and execution of global investigational submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL)
• Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
• Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges.
• Perform independent QC on prepared CTA submissions which include submission documents and structured data populated within the CTIS and IRAS submission portals.
• Act as a liaison while coordinating CTA activities with other multidisciplinary teams.
• Provide support for preparation, submission, lifecycle, and archival of CTA submissions and correspondences.
• Assist with development of assigned regulatory operations work instructions.
• Stay abreast with updates for regulatory and/or industry standards

Required Competencies

• Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019.
• Demonstrated performance in managing and producing time-intensive deliverables.
• Strong attention to detail in data entry accuracy and in following specific process steps within procedural documents.
• Knowledge of Document Management Systems (Documentum-based is preferred)
• Recent experience in submitting regulatory submissions using Health Authority Portals.
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint.
• Recent experience with regulatory applications such as CTAs is preferred.

Skills

• Proven performance in managing and producing quality time-intensive deliverables.
• Highly developed project management skills
• Proven ability to solve complex issues through innovative problem solving
• Well defined written and oral communication skills
• Knows how/when to apply organizational policy or procedures to a variety of situations
• Demonstrates flexibility in dealing with change and diversity.
• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment.
• Successfully engaged in multiple initiatives simultaneously.