Senior Regulatory Publisher

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

Job summary

A leading company in regulatory solutions seeks a Regulatory Affairs Specialist-Publishing to join their dynamic team. The role involves preparing and validating regulatory submissions and requires a BSc in life sciences with at least 5 years of relevant experience. This position offers the opportunity to work in a collaborative environment, contributing to the future of regulatory services.

Qualifications

• Minimum 5 years of direct experience with Regulatory Affairs Publishing.
• Experience with regulatory submission formats including eCTD.
• Knowledge of regulatory requirements (FDA, EMA, ICH).

Responsibilities

• Prepare, publish, review, validate, and dispatch regulatory submissions.
• Produce high-quality, HA-compliant submission outputs.
• Collaborate with global teams for timely submissions.

Skills

Communication

Project Management

Time Management

Analytical Skills

Problem Solving

Education

BSc in life sciences or related field

Tools

MS Office

Job description

Job Title: Regulatory Affairs Specialist-Publishing

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

Experience: Minimum 5 years of direct experience with Regulatory Affairs Publishing

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 complexities.

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:

Apply through this job post or visit our Careers page for more openings.

Responsibilities:

• Prepare, publish, review, validate (using eCTD validator), and dispatch regulatory submissions (e.g., INDs, BLAs/NDAs, MAAs, etc.).
• Produce high-quality, HA-compliant submission outputs in formats like eCTD, NeeS, and Paper, adhering to timelines and requirements worldwide.
• Collaborate with global teams across US, EU, and India, ensuring timely and quality submissions.
• Liaise with cross-functional teams to ensure high-quality, timely submissions.
• Follow internal guidelines and support new technology and process implementations.
• Identify and resolve process or technical issues, contributing to process improvements and knowledge sharing.

Minimum Requirements:

• BSc in life sciences or related field with at least 5 years of pharma or related industry experience.
• Experience with regulatory submission formats and publishing activities, including eCTD.
• Knowledge of regulatory requirements and guidelines (FDA, EMA, ICH).
• Strong communication, project management, and time management skills.
• Ability to work independently and with cross-functional teams.
• Proficiency in MS Office and quick learner of new systems.
• Analytical and problem-solving skills.