Hybrid Senior Regulatory Operations Associate

at ICON plc

• Job title: Senior Regulatory Operations Associate
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: No Education Requirement
• Tech skills: Assembly
• Location requirements: Hybrid, Warsaw, Poland

About the role

• Support regulatory submissions and document management at ICON plc, a leading clinical research organization. Requires fluency in English and Russian with operational publishing responsibilities.

Responsibilities

• Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions.
• Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
• This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.
• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
• Maintain submission components associated with a regulatory submission, paper and/or electronic, as required.
• This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
• Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software.
• Perform quality review of Regulatory Operations team members work to ensure accuracy.
• Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.
• Maintain current knowledge of applicable regulations and industry best practices.
• Participate in the interpretation of guidelines and impact assessment to current work procedures.
• Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.
• Assist in the design and implementation of new processes or initiatives within the department.
• Participate in special projects and carry out assigned activities in support of the Publishing function.

Requirements

• Ideally you will have 1-2 years relevant experience
• Excellent communication skills and fluency in English and Russian
• Ability to work independently

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.