Sr Associate, Global Regulatory Systems & Process Management (GRSPM) will support GRSPM Head with management and coordination of systems and process within Global Regulatory Services and Operation team. This position will support Regulatory Systems initiatives contributing directly to the value of Global Regulatory Operations, and responsible for oversight and local level systems support for Global Regulatory Affairs. This position will also contribute to Process Excellence by evaluating, developing and providing input into existing and proposed processes. We are looking for a solution oriented person who ensures that deliverables and key submission targets are achieved according to the quality standards of Client’s standard operating procedures.
1. Ensure that Regulatory Information Systems are supported and managed according to business need, including, but not exclusively, FirstDoc, eCTD Express, Submission Viewer, Veeva Vault for Registrations and SharePoint. Processing and responding to change requests for systems or processes, additionally helpdesk type duties for the support of our business users.
2. Submission Management Support: this comprises business end user support of the Submission Management publishing tools and business processes for the GRO department.
3. Create and deliver Training to Business System Users: this will include identifying the training needs and these end users
4. Assume role as IT liaison. This will include managing system change request management and issue escalation.
5. Vendor Management: Working with vendors to manage change requests, Service Level Agreements and Compliance Management.
6. Engage with vendors and internal partners to drive future state of-the shelf software packages.
7. User Requirement Gathering and Dissemination, Process Design.
8 Service Request Management.
9. Gathering Business Feedback and Group Activity/Initiatives.
• BS/BA with 3 years of regulatory submission related experience. Alternatively, 8+ years of hands on experience in regulatory submission/publishing without bachelor degree will be considered.
• Previous experience in pharmaceutical industry an advantage
• Experience with Systems, in particular in relation to Document Management, Regulatory Tracking and Publishing is beneficial
• Knowledge of Regulatory and Submissions processes in the EU and US is also important, especially with knowledge for key Regulatory systems and report publishing
• Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus
• Experience of mapping User Requirements to Functional Specifications especially in respect of process management an advantage
• 1st and 2nd line experience support around regulatory systems
Source: Job Diva – Job Listing