Regulatory Affairs Manager

Please do not apply if you are not located in UK / EU

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 Clinical Trials

Location : UK

Key Skills : EU-CTR / CTIS, MHRA, ARSAC submissions, UK Submission, IRAS, UK Study Start up

Description

Essential:

• Experience with leading MHRA, REC and study-wide review submissions under the combined review in the new IRAS
• Experience in UK study start-up:
• ARSAC submissions
• Pharmacy Assurance applications
• Radiation Assurance applications

Highly preferrable:

• Experience in UK study start-up:
• Experience with Self-managed Radiation assurance

Optional (plus):

• Specialized knowledge in UK study start-up:
• CRN network (National Institute for Health Research (NIHR) Clinical Research Network) submissions
• Communicating amendments to sites