Regulatory Affairs Specialist - RIMS

Please do not apply if you are located outside EU/UK

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

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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 service

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!

Title : Regulatory Affairs Associate / Specialist - RIMS

Location : UK

Experience : 3+ years in RIMS with Labelling

Description

Summary:

The Regional RIM Support Specialist will support one or more Client’s Local Operating Companies (LOCs) for regulatory business process execution in the Regulatory Information Management system and related systems.

The candidate demonstrates a strong understanding of international and regional regulatory requirements, advanced knowledge of Veeva RIM systems data model, data entry and EDMS, and practical experience delivering training and supporting end users.

This role is an opportunity to support a global information management team and international regulatory functions to execute business processes to a high standard, and to ensure the integrity of data used internally for business intelligence/reporting purposes and externally to comply with global regulatory agency information requests and obligations.

Responsibilities:

· Supports questions from information providers specific to RIM and related system business process

· Delivers and/or provides extended support for training to information providers for new and updated processes

· Works with Data Governance team to ensure data integrity and where appropriate, identifies, tracks, and supports remediation activities specific to business process

· Establishes and maintains regular contact with information providers, verifiers, and key stakeholders

· Responsible for identifying internal process issues/risks/ deficiencies to RIM Support Coordinator and working with RIM Team as necessary to update processes

· Identifies, logs, and tracks issues raised by information providers and team members through to resolution; responds to information provider requests independently and collaborates with RIM Support Coordinator and/or RIM Team to help identify and implement optimal solutions

· Remains current on regional regulatory changes and requirements to ensure compliance with regulations and ensure impacted business processes are identified for update or enhancement

· Support the creation of local user guides as identified by the RIM Team

Required Qualifications

· 2-5 years Registration Management experience

· Strong working knowledge of RIM systems, specifically Veeva Vault RIM

· Learns quickly and has the ability to work independently but seek management support and guidance as needed

· Working knowledge of external data standards, e.g., pharmacopeia, standard terms, SPOR, ISO, MedDRA

· Working knowledge of Global Regulatory Affairs as well as understanding of European, US and international regulations relative to RIM

· Working knowledge of regulations specific to supported region

· Practical experience managing regulatory data in a controlled Regulatory Information Management to defined quality standards

· Previous experience with EDMS, regulatory submission process, compliance requests, submission management, or regulatory informatics data entry

· Previous experience in a training and customer support capacity

· Good overall understanding of Pharmaceutical Development processes

· Skilled with MS Word, Excel, PPT