Job Board

Companies

Freyr Solutions

Regulatory Affairs Consultant (Remote)

Guernsey Full-Time 36000 - 60000 £ / year (est.) No home office possible

At a Glance

Tasks: Support regulatory submissions and collaborate with teams to ensure compliance in the Life Sciences sector.
Company: Freyr is an innovative company providing regulatory solutions for the pharmaceutical and biotech industries.
Benefits: Enjoy remote work flexibility and be part of a dynamic, collaborative team culture.
Why this job: Join us to make a real impact in regulatory services and shape the future of compliance.
Qualifications: 4-6 years in Regulatory Affairs; a degree in life sciences or related field is preferred.
Other info: This role is remote but candidates should be based in the UK or EU.

The predicted salary is between 36000 - 60000 £ per year.

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.

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 on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

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.

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.

Regional Regulatory Liaison Support

Support a regional regulatory lead (RRL) in the EU, or IC/GPS (RoW) region.
Support execution of RA/regional strategy for assigned projects by:

Providing support as defined by the RRL, to help advance the project in-line with client’s Corporate Objectives and governance goals.
Participating in regulatory project teams and development forums.
Building and maintaining partnerships with other members of RA.

Provide support in the preparation of regulatory submissions for investigational and commercial products, including clinical study applications and supplements to marketing authorizations in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Work with functional sub-teams to develop a timeline based on data availability and other critical path activities. Maintain timeline during the project lifecycle.

With guidance, works to develop and acquire required regulatory skills and knowledge.

May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

May act as a resource on a specific topic for other Regulatory personnel within the department.

Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.

Act as support to the Regional Regulatory Liaison for the assigned products, compounds, indications or projects in the assigned therapeutic area.

Will be typically assigned multiple products or projects to manage simultaneously, with guidance, may lead the regulatory activities for assigned products or projects.

Taking the lead on regulatory submissions including the preparation, compilation, and timely filing of the submissions, while seeking guidance from more experienced colleagues as needed.

Renewals, labelling support to post-licensing activities including labelling variations, responses to questions, PSUR/RMP to the client for dispatch to a local partner or Affiliate.

Represents Regulatory Affairs on relevant cross-functional teams and advises cross-functional partners and stakeholders on the requirements and pathway needed to obtain, change or maintain licensure, optimal listing and compliance with regulatory authorities.

Provide direction on and managing associated activities and needs for regulatory labelling and packaging.

Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, and practices.

Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

BA/BS or advanced degree in life sciences or related field with some regulatory experience or related work experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.

Performs a broader range of regulatory affairs activities with supervision from more experienced colleagues. Able to advise cross-functional partners on standard regulatory requirements and pathways needed to meet regulatory and other business goals and objectives. Completes most core regulatory affairs activities for moderately complex products and filings that enable other Global TA Regulatory Liaison colleagues to focus on more complex products or projects. Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.

Regulatory Affairs Consultant (Remote) employer: Freyr Solutions

Freyr is an exceptional employer that champions a collaborative and innovative work culture, making it an ideal place for Regulatory Affairs professionals to thrive. With a strong commitment to employee growth, we offer numerous opportunities for skill development and career advancement, all while working remotely from the comfort of your home in the UK or EU. Join us at Freyr, where you can make a meaningful impact in the Life Sciences industry and be part of our exciting journey towards redefining regulatory excellence.

Contact Detail:

Freyr Solutions Recruiting Team

View Freyr Solutions Profile

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Affairs Consultant (Remote)

✨Tip Number 1

Familiarise yourself with the specific regulatory frameworks relevant to the Life Sciences industry, especially those applicable in the EU. Understanding the nuances of ICH requirements and regional regulations will give you a significant edge during discussions.

✨Tip Number 2

Network with professionals already working in Regulatory Affairs, particularly those at Freyr or similar companies. Engaging in conversations about their experiences can provide insights into the company culture and expectations, which can be invaluable during interviews.

✨Tip Number 3

Stay updated on the latest trends and changes in regulatory policies within the biopharma sector. Being able to discuss recent developments or challenges in the field during your interview will demonstrate your commitment and knowledge.

✨Tip Number 4

Prepare to showcase your ability to work collaboratively in cross-functional teams. Highlight any past experiences where you successfully contributed to team projects, as this aligns with Freyr's emphasis on collaboration and dynamic work environments.

We think you need these skills to ace Regulatory Affairs Consultant (Remote)

Regulatory Knowledge

Project Management

Attention to Detail

Communication Skills

Analytical Skills

Understanding of ICH Guidelines

Clinical Study Application Preparation

Submission Compilation and Filing

Cross-Functional Collaboration

Problem-Solving Skills

Time Management

Knowledge of Labelling and Packaging Regulations

Ability to Work Under Supervision

Adaptability to Regulatory Changes

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs, particularly any roles that involved regulatory submissions or compliance in the Life Sciences industry. Use keywords from the job description to align your skills with what Freyr is looking for.

Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for regulatory affairs and your desire to contribute to Freyr's mission. Mention specific projects or experiences that demonstrate your ability to support regulatory strategies.

Showcase Relevant Skills: In your application, emphasise skills that are crucial for the role, such as project management, attention to detail, and knowledge of ICH requirements. Provide examples of how you've successfully applied these skills in previous positions.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your professionalism and attention to detail, which are essential in the regulatory field.

How to prepare for a job interview at Freyr Solutions

✨Understand Regulatory Affairs Fundamentals

Make sure you have a solid grasp of the key concepts and regulations in the life sciences industry. Familiarise yourself with ICH guidelines and regional requirements, as this knowledge will be crucial during your interview.

✨Showcase Your Project Management Skills

Be prepared to discuss your experience managing multiple regulatory projects simultaneously. Highlight any specific examples where you successfully maintained timelines and collaborated with cross-functional teams.

✨Demonstrate Your Problem-Solving Abilities

Freyr values innovation and excellence, so come equipped with examples of how you've contributed to process improvements or tackled challenges in previous roles. This will show your proactive approach and ability to adapt.

✨Ask Insightful Questions

Prepare thoughtful questions about Freyr's regulatory strategies and the team dynamics. This not only shows your interest in the role but also helps you gauge if the company culture aligns with your values.

Regulatory Affairs Consultant (Remote)

Guernsey

Full-Time

36000 - 60000 £ / year (est.)

Application deadline: 2027-06-01
Freyr Solutions

View Freyr Solutions Profile

Similar positions in other companies

UK’s top job board for Gen Z

Discover now