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- Tasks: Support regulatory submissions and collaborate with teams to ensure compliance in the Life Sciences industry.
- Company: Freyr is an innovative company providing regulatory solutions for pharmaceutical and biotech sectors.
- 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.
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) employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist (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 case studies during your interview can demonstrate your passion and commitment to the field.
✨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 handled complex timelines and collaborated with cross-functional teams.
We think you need these skills to ace Regulatory Affairs Specialist (Remote)
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 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 showcases your passion for regulatory affairs and your understanding of the complexities involved in the field. Mention specific experiences that demonstrate your ability to support regulatory projects and work collaboratively with teams.
Highlight Relevant Skills: In your application, emphasise skills such as project management, attention to detail, and knowledge of ICH requirements. These are crucial for the role and will help you stand out as a candidate who can contribute effectively to Freyr's objectives.
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 traits for a Regulatory Affairs Specialist.
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Affairs Basics
Make sure you have a solid understanding of the key principles of regulatory affairs, especially in the life sciences sector. Be prepared to discuss your experience with regulatory submissions and compliance, as this will be crucial for the role.
✨Showcase Your Collaborative Skills
Freyr values a collaborative work environment, so highlight your ability to work effectively within teams. Share examples of how you've successfully partnered with cross-functional teams in previous roles to achieve regulatory goals.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss specific challenges you've faced in regulatory affairs and how you overcame them. This will show your potential employer that you can handle the complexities of regulatory compliance and contribute to process improvements.
✨Prepare Questions About Their Vision
Research Freyr's mission and recent developments in the regulatory landscape. Prepare insightful questions about their strategies and how you can contribute to their growth, demonstrating your genuine interest in the company and its future.
