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Regulatory Affairs Manager

Freyr SolutionsUnited Kingdom, United Kingdom

29 days ago

Job description

This role is open for candidates in EU / UK only. Applications from other locations will not be considered

About the job

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 to Warsaw, Poland, 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's new chapter in Warsaw, Poland. 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 : UK / Germany / Poland / Romania

Key Skills : EU-CTR / CTIS.

Job Description :

Regulatory Affairs Manager

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.