At a Glance
- Tasks: Manage global regulatory submissions and ensure compliance with health authorities.
- Company: Freyr is an innovative leader in regulatory solutions for the Life Sciences industry.
- Benefits: Enjoy remote work flexibility and be part of a dynamic, collaborative team.
- Other info: This role offers a chance to work with cutting-edge regulatory technologies.
- Why this job: Join us to make a real impact in regulatory services and shape the future of compliance.
- Qualifications: Bachelor’s or Master’s in Life Sciences; 5 years in regulatory operations preferred.
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.
Why Freyr?
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.
Join Our Team:
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.
To Apply:
Please apply to this job post or you can visit our Careers page for more openings
Visit our Careers page at ( to explore current job openings and submit your application.
Don\'t miss this chance to be a part of Freyr\'s expansion and make your mark in the world of regulatory services. Let\'s redefine regulatory excellence together!
Position Title: Regulatory Submissions Manager
Department: Regulatory Submission Management (RSM)
Location: Remote ( Base location should be UK)
Role Summary:
As a Regulatory Submissions Manager at Freyr, you will play a pivotal role in managing the operational lifecycle of global regulatory submissions. This includes planning, coordinating, and executing submission content plans in alignment with regional and international regulatory requirements. You will serve as a key liaison between regulatory affairs, publishing, and cross-functional teams, ensuring timely and compliant submissions to Health Authorities worldwide.
Key Responsibilities:
- Develop and maintain compliant content plans for submissions across the US, EU, ACE, and select IC/GPS markets.
- Oversee submission planning, document collection, and content plan execution from an operational standpoint.
- Draft and review select Module 1 documents, including cover letters and regulatory forms.
- Collaborate with Global and Regional Regulatory Leads, publishing teams, and internal stakeholders to align on timelines and resolve submission-related challenges.
- Manage metadata and templates for submission components using systems like Veeva Vault.
- Track submission progress, identify risks, and communicate status updates to stakeholders.
- Ensure timely dispatch of dossiers to Health Authorities and maintain accurate archival of submission records.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences or a related field.
- Minimum of 5 years of experience in regulatory operations; experience in regulatory affairs is a strong advantage.
- Hands-on experience with regulatory content management systems such as Veeva Vault or equivalent.
Skills & Competencies:
- In-depth understanding of ICH guidelines and regional regulatory frameworks, including eCTD and other submission formats.
- Strong project management skills with the ability to handle multiple priorities and deadlines.
- Excellent communication and interpersonal skills for effective collaboration across global teams.
- Ability to navigate complex regulatory environments and maintain oversight of submission planning and execution.
- Proficiency in using regulatory IT platforms and tools.
Regulatory Submission Manager in Watford employer: Freyr Solutions
Freyr is an exceptional employer that champions a collaborative and dynamic work culture, empowering employees to make a significant impact in the Life Sciences industry. With a focus on innovation and excellence, Freyr offers ample opportunities for professional growth and development, all while providing the flexibility of remote work from the UK. Join us to be part of a forward-thinking team dedicated to redefining regulatory services and making a meaningful difference.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submission Manager in Watford
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the role, such as ICH guidelines and eCTD formats. This knowledge will not only help you understand the job better but also demonstrate your commitment and expertise during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with companies like Freyr. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory submissions.
✨Tip Number 3
Gain hands-on experience with regulatory content management systems, particularly Veeva Vault. If you haven't used it before, consider taking online courses or tutorials to boost your skills, as this will be a significant advantage in your application.
✨Tip Number 4
Prepare for the interview by thinking of examples from your past experiences that showcase your project management skills and ability to handle multiple priorities. Be ready to discuss how you've successfully navigated complex regulatory environments in previous roles.
We think you need these skills to ace Regulatory Submission Manager in Watford
Some tips for your application 🫡
Understand the Role:Before applying, make sure you fully understand the responsibilities of a Regulatory Submissions Manager. Familiarise yourself with the key tasks mentioned in the job description, such as managing submission content plans and collaborating with cross-functional teams.
Tailor Your CV:Customise your CV to highlight relevant experience in regulatory operations and any hands-on experience with systems like Veeva Vault. Emphasise your project management skills and understanding of ICH guidelines to align with the qualifications Freyr is seeking.
Craft a Compelling Cover Letter:Write a cover letter that showcases your passion for regulatory affairs and your ability to navigate complex regulatory environments. Use specific examples from your past experience to demonstrate how you can contribute to Freyr's mission of regulatory excellence.
Proofread and Edit:Before submitting your application, carefully proofread your CV and cover letter 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 Frameworks
Familiarise yourself with ICH guidelines and regional regulatory frameworks relevant to the role. Be prepared to discuss how your experience aligns with these regulations and how you can navigate complex environments.
✨Showcase Project Management Skills
Highlight your project management experience, especially in handling multiple priorities and deadlines. Use specific examples from your past roles to demonstrate your ability to manage submission planning and execution effectively.
✨Communicate Effectively
Since collaboration is key in this role, practice articulating your thoughts clearly. Prepare to discuss how you've successfully worked with cross-functional teams and resolved challenges in previous positions.
✨Demonstrate Technical Proficiency
Be ready to talk about your hands-on experience with regulatory content management systems like Veeva Vault. Discuss any relevant tools or platforms you've used and how they contributed to successful submissions.
