Ra Manager Uk Ctr (Remote)

About Freyr:

Freyr is the largest global provider of Regulatory Solutions & Services, supporting large, mid-sized, and small Life Sciences companies throughout their entire Regulatory value chain. Our services encompass Regulatory Strategy, Intelligence, Dossiers, Submissions, Post-Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and related functions.

Job Title: RA Manager – UK CTR

Work Location: Remote

Working Hours: 8 AM to 5 PM (GMT)

Essential Duties and Responsibilities (included but not limited to the following; other duties may be assigned):

• Support necessary submission activities for CTAs under UK Clinical Trial Regulations.
• Prepare and submit CTAs within the MHRA Integrated Regulatory Submission (IRAS) portal in accordance with regulatory requirements, using Submission Management tools and an EDMS system.
• Perform independent QC on prepared CTA submissions, ensuring accuracy and completeness of submission documents and structured data within the HA submission portals.
• Monitor the IRAS submission portal for notices and alerts from the MHRA, providing communications to the appropriate Functional Areas (FAs) in accordance with timelines and processes.
• Maintain oversight of user management for CTA-required systems and tools.
• Act as a liaison while coordinating CTA activities with multidisciplinary teams.
• Provide expertise on IRAS portal processes to relevant FAs during the preparation and submission of CTA documents.
• Support the preparation, submission, lifecycle management, and archival of CTA submissions and associated correspondences.
• Assist with developing regulatory operations work instructions specific to UK requirements.
• Perform User Acceptance Testing (UAT) for submission management tools as required.
• Participate in the evaluation of new technologies for Regulatory Operation needs.
• Stay updated with UK regulatory standards and industry guidelines related to clinical trial submissions.

Required Competencies:

• Comprehensive knowledge of UK Clinical Trial Regulation and The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019.
• Demonstrated success in managing time-sensitive, high-quality deliverables.
• Strong attention to detail in data entry and adherence to specific process steps.
• Familiarity with Document Management Systems (Documentum-based preferred).
• Recent experience submitting regulatory documents through Health Authority portals (IRAS preferred).
• Proficient computer skills, including Microsoft Office suite (Word, Excel, PowerPoint, and Access), and SharePoint.
• Previous experience with regulatory applications like CTAs is advantageous.

Skills:

• Proven performance in producing quality deliverables under tight deadlines.
• Advanced project management skills.
• Strong problem-solving abilities with a focus on regulatory challenges.
• Excellent written and verbal communication skills.
• Ability to apply organizational policies and adapt to diverse regulatory scenarios.
• Flexible and collaborative in a global, multicultural work environment.
• Proven ability to handle multiple projects simultaneously.

Education and Experience:

• Bachelor’s degree in Science, Arts, or equivalent professional experience.
• Regulatory operations experience, with in-depth exposure to electronic submission processes for UK CTAs.

At Freyr Inc, we are dedicated to fostering a culture of excellence, innovation, and collaboration, driving success for our clients and advancing global healthcare. We value our employees as our greatest asset and are always seeking passionate, talented individuals to join our team. By working at Freyr, you will make a significant impact in the life sciences industry, contributing to cutting-edge regulatory solutions and services. We offer a dynamic, inclusive environment where your ideas are valued, and your professional growth is supported. If you are eager to take on new challenges and make a difference in global healthcare, Freyr is the place for you. Come be a part of our journey and help shape the future of healthcare.