Regulatory Submission Manager

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 (https://www.freyrsolutions.com/careers/current-positions) 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.