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 to Warsaw, Poland, 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's new chapter in Warsaw, Poland. 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!

Title :Regulatory Data Governance Coordinator - RIMS

Location :Remote but open ONLY to candidates based in Europe (UK / Poland / Germany). Applications from other locations will not be considered.

Description

Summary:

The Regulatory Data Governance Coordinator will ensure Regulatory information and data standards are aligned with client’s strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations).

Working closely with Management team and key stakeholders, he/she will have the opportunity to assist the team in integrating data assets from a variety of systems and sources into Company’s RIM systems, ensuring and monitoring the final quality of our internal data stores and flows.

The ideal candidate is a strong collaborator and partner, is focused on process improvement, quality and efficiency, and can navigate a highly federated organization. This individual has applied experience with metadata and data catalog management within a large organization and will be an advocate for best practices in metadata creation, management, and distribution across all Regulatory functions and partners.

Responsibilities:

• Oversee the establishment and execution of Regulatory data governance policies.
• Oversee data quality process operations, assign available resources. Track and report on progress of key data initiatives.
• Report on data quality metrics to key stakeholders and management.
• Engage with standard data governance roles (Data Quality Analyst, Data Stewards, Data owner) for the regulatory data domain.
• Maintain the Regulatory Data Catalog: Document Data classification and quality rules.
• Oversee Regulatory Document data classification rules, compliance/retention rules, and business rules and access policies.
• Leads efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance with internal and regulatory policies.
• Define process, frequency, and responsibility for identification of metadata discrepancies and resolution.
• Ensures that the metadata framework captures all relevant metadata needed for regulatory needs as well as data management compliance,
• Drives adoption of metadata management practice through training and effective change management across stakeholder groups.
• Participate in forums (with other domain trustees/stewards, etc.) to communicate change management and address specific issues related to their domain and business unit.
• Support Change Management and Regulatory Intelligence assessment processes to evaluate impact on Regulatory Data.
• Assess impact of system changes on data governance assets.
• Support definition of RIM data Roadmap, RIM Architecture diagrams, Interface Specifications as SME.

Required Qualifications

• 5+ years of experience in Healthcare/Pharmaceutical industry
• 5+ years of relevant work experience in data management/data governance role
• Must Have strong experience and advanced understanding of the collection and management of regulatory data and regulatory documents (5+ years).
• A desire to be a hands-on contributor, pro-active and be able to drive direction of work that needs to be completed.
• Knowledge of Metadata Management and Master Data Governance best practices.
• Must be able to identify, analyze and address problems to resolve issues whenever possible in way that minimizes negative impact and risk to the organization.
• Familiar with Data Catalog and Data Catalog / Data Management Tool (Collibra or other)
• Understanding of Pharmaceutical Data Standards; US and International (ISO, ICH, IDMP, SPOR, EDQM, XEVMPD, PQ CMC…)
• Analytical / Problem solving skills
• Familiarity with Veeva RIM Data Model
• Experience with Labeling, CMC and Regulatory processes
• Experience implementing technology solutions either as a project, technical, or functional lead
• Experience with public and hybrid cloud environments
• Experience working in a GxP environment preferred