Regulatory Affairs Specialist

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

Job summary

A leading regulatory solutions provider is expanding its team and seeking a Regulatory Affairs Specialist. This role involves supporting regulatory strategies, preparing submissions, and engaging with cross-functional teams. Candidates should possess 4-6 years of relevant experience and a strong educational background in life sciences, with exceptional communication and organizational skills.

Qualifications

• 4-6 years of experience in Regulatory Affairs.
• Knowledge of health authorities and regulatory pathways.
• Strong communication and organizational skills.

Responsibilities

• Support a regional regulatory lead with strategies and project execution.
• Prepare regulatory submissions in line with ICH and regional requirements.
• Develop timelines and handle routine labelling changes.

Skills

Rest of World Experience

Lifecycle Management

Labelling

PSUR

Safety Reports

Education

Bachelor's or higher degree in life sciences

Job description

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Regulatory Affairs Specialist, Wakefield

Client: Freyr Solutions

Location: Wakefield, 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 providing end-to-end regulatory solutions for the Life Sciences industry, aiding pharmaceutical, medical device, and biotech companies in regulatory compliance.

Why Freyr?

We foster a collaborative environment and are expanding our team. We seek passionate Regulatory professionals to help shape the future of regulatory services.

Join Our Team:

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

How to Apply:

Apply through this job post or visit our Careers page: https://www.freyrsolutions.com/careers/current-positions

Be part of Freyr's expansion and make your mark in regulatory services.

Position: Regulatory Affairs Specialist / Sr. RA Specialist

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

Experience: 4-6 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 region, assisting with regulatory strategies and project execution, participating in teams, and maintaining partnerships.

Key Activities include:

• Preparing regulatory submissions for investigational and commercial products in line with ICH and regional requirements.
• Developing timelines, handling routine labelling changes, and contributing to process improvements.

Experience & Skills:

• Bachelor's or higher degree in life sciences or related field with regulatory experience.
• Knowledge of health authorities, regulatory pathways, and ability to advise cross-functional teams.
• Strong communication, organizational, negotiation, and conflict resolution skills.