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-Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

• S upport regulatory teams by ensuring seamless data entry, document management, and workflow automation.
  A) Assist in the preparation, submission, and tracking of regulatory filings through Veeva RIM.
  B) Stay updated on Veeva Vault enhancements and industry trends.
  C) Assist with data migration and integration tasks.
  D) Document processes and procedures for Veeva Vault RIM implementations.
  E) Generate reports and dashboards for regulatory performance tracking and compliance monitoring.
• Maintain good working relationships with relevant RA, non-RA stakeholders and - when relevant - Health Authorities.
• Alternatively, support creation and / or maintenance of relevant training materials, work instructions and SOPs. Make sure that documentation is archived according to given rules.
• Alternatively, support initiatives to improve and / or increase the harmonization of business processes in the area of ROPS and ensure that updated processes are followed.
• Support a timely implementation of new or updated business processes on local and global level and coordinate trainings as appropriate.
• Maintain different regulatory databases on a timely basis and provide the essential reports and information to enable internal stakeholders to make informed decisions.
• Monitor and ensure that RA business intelligence (including regulatory guidelines) is applied to internal processes and systems in a timely matter.
• Support onboarding of new associates into the organization and into the tasks

What you ll bring to the role: Essential Requirements:

• Minimum 3 years of work experience in RIMS
• Good knowledge of Regulatory Affairs processes
• Knowledge of Regulatory guidelines is a plus.
• Ability to work under pressure, demonstrating initiative and flexibility.
• Attention to detail and quality focused.
• Team spirit and embracing diversity of cultures and personalities

• Veeva Vault
• Documentation Management.
• Operational Excellence