Regulatory Affairs Specialist

JR United Kingdom; Telford; Remote; GBP 40,000 - 70,000; Full time

Job summary

A leading company in regulatory solutions for Life Sciences seeks a Regulatory Affairs Specialist with 4-6 years of experience. The role involves supporting regional regulatory strategies, preparing submissions, and ensuring compliance. Join a dynamic team to shape the future of regulatory services in a collaborative environment.

Qualifications

• 4 to 6 years of experience in Regulatory Affairs.
• Knowledge of health authorities and regulations.
• Strong interpersonal and communication skills.

Responsibilities

• Support execution of RA/regional strategy for projects.
• Prepare regulatory submissions for investigational and commercial products.
• Lead regulatory activities such as submissions, amendments, and safety reports.

Skills

Rest of World Experience

Lifecycle management

Labelling

PSUR

Safety Reports

Education

Degree in life sciences or related field

Job description

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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 looking 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 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 the world of regulatory services. Let's redefine regulatory excellence together!

Position: Regulatory Affairs Specialist / Sr. RA Specialist

Location: Remote (Base location should be in UK/EU, preferably in UK, Hungary, Poland, Romania, Czech Republic, or 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 (RRL) in the EU or IC/GPS (RoW) region by:

• Supporting execution of RA/regional strategy for projects
• Participating in regulatory project teams and forums
• Working across franchises or TAs
• Building partnerships within RA
• Acting as a delegate for RRL when needed

Key Activities

Include, but are not limited to:

• Preparing regulatory submissions for investigational and commercial products
• Developing timelines and managing critical path activities
• Handling routine labelling changes and drug listings
• Developing regulatory skills and knowledge
• Contributing to process improvements within Regulatory Affairs

Experience & Skills

Support the Regional Regulatory Liaison for assigned products or projects, managing multiple simultaneously, with guidance. Lead regulatory activities such as submissions, amendments, renewals, and safety reports. Provide regulatory strategy input, ensure compliance, and advise cross-functional teams.

Requirements include a degree in life sciences or related field, regulatory experience, knowledge of health authorities, and strong interpersonal, communication, organizational, negotiation, and conflict resolution skills.