RIM Expert

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What The Job Looks Like
Each day you'll enjoy a variety of challenges, such as:

• Implementation of Next Generation Regulatory Information Management system, system demonstrations, training sessions, business testing of system functionality and supporting  roll out of the system in the region (LatAM)
• Lead / support region specific preparatory activities in the programme
• Lead / Support requirements gathering, analysis and implementation of new regional / country specific regulatory requirements in global RIMS
• Training & Change Management
• Perform the role of RIM ambassador in the region, supports training & change management to ensure successful adoption of the platform in the region
• Works in close collaboration with counties / affiliates in the region to understand challenges & concerns with RIM system & processes, and works with the global RIM team in ensuring required solutions are implemented
• Supports creation of user guides, best practices for the appropriate usage of  Global RIMS in the region
• Registrations Data Management
• Leads / Support RIM data quality initiatives & maintenance corresponding to the region
• Enters selective data related to product registrations & lifecycle maintenance as per implemented business process, into GRT’s Regulatory Information Management System (RIMS). 
• Co-ordinates with local affiliates / countries in the region in ensuring high quality data is maintained within RIMS
• Ensures data conforms to the implemented regulatory data standards & policies
• Eg. Ensures entered data is verified against relevant authoritative sources of information, such as approval letter, labels, dossiers, etc.
• Support with uploading specific documents into RIMS, such as agency correspondences, approval letters, dossiers, partner documents, etc.
• Ensures data conforms to the implemented regulatory data standards & policies
• Submission Management Process:
• Co-ordinates with product teams to track completion of submission content plans
• Builds submission dossiers as per the finalized submission content plan
• Build, Hyperlink, Compile, Validate & Publish submission sequences in eCTD format (current not in LatAM)
• Build, Validate & Publish submissions in NeeS format
• Performs submissions to health authorities where appropriate
• Other Operational Activities:
• Assesses trends and upcoming changes in the regulatory requirements within the region to support determining impact to RIMS
• Actively leads and/or contributes to the creation, maintenance of and adherence to optimal standardized and compliant processes within RIMS
• Supports implementation and maintenance of standardized processes and process improvements within RIMS
• Monitors data quality against defined KPIs, supports with continuous improvement to achieve the desired KPIs
• Supports with reporting of data & information from RIMS

What You'll Bring To The Table
To make the most of this role and truly thrive, you should have:

• University Degree in courses related to Life Sciences / Regulatory Affairs / Systems & Data Management
• Experience & good understanding of Regulatory Information Management processes
• Working experience with regulatory affairs & good understanding of processes supporting lifecycle maintenance of marketed products
• Previous experience working with Regulatory Information Management systems & technologies, such as Documentum, Veeva Vault.