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- 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 30000 - 42000 £ 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.
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 Specialist - Remote Working employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist - Remote Working
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to the Life Sciences industry, especially those pertaining to the EU and UK. 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 project management skills, as this role involves managing multiple products or projects simultaneously. Think of examples from your past experience where you successfully led regulatory submissions or collaborated with cross-functional teams.
We think you need these skills to ace Regulatory Affairs Specialist - Remote Working
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs, especially any roles that involved regulatory submissions or compliance in the life sciences sector. Use keywords from the job description to align your skills with what Freyr is looking for.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with Freyr's mission. Mention specific experiences that demonstrate your ability to support regulatory strategies and work collaboratively within teams.
Showcase Relevant Skills: Emphasise your understanding of ICH requirements and your experience with clinical study applications. Highlight any project management skills, as well as your ability to maintain timelines and manage multiple projects simultaneously.
Proofread and Edit: Before submitting your application, carefully proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the regulatory field.
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Affairs Basics
Make sure you have a solid understanding of regulatory affairs principles, especially in the life sciences sector. Brush up on ICH requirements and regional regulations, as these will likely come up during your interview.
✨Showcase Your Project Management Skills
Be prepared to discuss your experience managing multiple 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 be ready to share instances where you've contributed to process improvements or tackled complex regulatory challenges. This will show your proactive approach and ability to think critically.
✨Ask Insightful Questions
Prepare thoughtful questions about Freyr's regulatory strategies and how they navigate compliance challenges. This not only shows your interest in the company but also your understanding of the role's impact on their success.
