Regulatory Affairs Specialist

JR United Kingdom; High Wycombe; Remote; GBP 40,000 - 60,000; Full time

Job summary

A fast-growing company in the regulatory services sector is seeking a Regulatory Affairs Specialist to support EU and RoW regulatory activities. The ideal candidate will have a background in life sciences and 4-6 years of relevant experience, ready to join a collaborative environment focusing on regulatory excellence.

Qualifications

• 4-6 years experience in Regulatory Affairs required.
• Knowledge of health authorities and regulatory processes essential.
• Strong communication, organizational, negotiation, and conflict resolution skills.

Responsibilities

• Support regulatory submissions, develop timelines, and handle labelling changes.
• Represent RA in cross-functional teams and ensure compliance.

Skills

Lifecycle management

Labelling

PSUR

Safety Reports

Rest of World Experience

Education

BA/BS in life sciences or related field

Job description

Social network you want to login/join with:

Regulatory Affairs Specialist, High Wycombe

Client: Freyr Solutions

Location: High Wycombe, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 5

Posted: 31.05.2025

Expiry Date: 15.07.2025

Job Description:

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 assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.

Why Freyr?

We foster a collaborative and dynamic work environment that empowers our team. As we expand, we seek passionate regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team:

If you're ready for growth and innovation, connect with us to explore opportunities at Freyr. Let's redefine regulatory excellence together!

To Apply:

Please apply to this job post or visit our Careers page for more openings: https://www.freyrsolutions.com/careers/current-positions

Don't miss this chance to be part of Freyr's expansion and make your mark in regulatory services.

Title

Regulatory Affairs Specialist / Sr. RA Specialist

Location

Remote (Base location should be in UK/EU, preferably in UK, Hungary, Poland, Romania, Czech Republic, Croatia)

Experience

4 to 6 years in Regulatory Affairs

Key Skills

Rest of World Experience, Lifecycle management, Labelling, PSUR, Safety Reports

Role Summary

Support a regional regulatory lead in the EU or RoW regions, assisting in executing regional strategies, participating in project teams, and building partnerships within RA.

Key Activities

Assist in regulatory submissions, develop timelines, handle routine labelling changes, and contribute to process improvements.

Experience & Skillset

Support to regulatory activities, including submissions like CTA, MAA amendments, license renewals, and safety reports. Represent RA in cross-functional teams, advise on regulatory pathways, and ensure compliance. Basic understanding of regulatory roles and requirements, strong communication, organizational, negotiation, and conflict resolution skills.

Requirements

BA/BS in life sciences or related field, regulatory experience or related healthcare work. Knowledge of health authorities, regulatory processes, and good interpersonal skills.