Regulatory Submission Manager

About the role

ICON Strategic Solutions is hiring a Regulatory Submission Manager in Warsaw. Working in a sponsor-dedicated model, the role acts as the regional regulatory representative within study teams and leads the execution of operational submissions for designated Clinical Trial Applications (CTAs) as part of the Regulatory Affairs team.

Key responsibilities

• Drive global submission management strategy and activities for assigned protocols and manage regulatory activities, standards and deliverables for CTA submissions
• Lead and attend meetings to set realistic timelines, understand project strategy and report on submission delivery status
• Ensure submissions meet industry, agency and format guidelines, regulatory strategies and timelines
• Liaise with the Sponsor Core team, SSU and Study Management on core documents and local documentation for HA and EC submissions and translation
• Prepare, review and support Sponsor submissions to the HA/Regional CTA Hub to obtain authorisations for clinical trials
• Coordinate translations of core documents and help compile the core package and authoring documentation
• Monitor the RFI mailbox and CTIS portal proactively and report RFIs to study teams; may also handle payments and act as local country liaison when required
• Resolve issues affecting submission builds or delivery and discuss dossier requirements with Sponsor subject matter experts

Required profile

• Bachelor's degree in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered
• In-depth understanding and proven execution of CTA and Central Ethics processes
• Proven technical aptitude and ability to quickly learn new software, regulations and quality standards
• Legal right to work in the country where the role is based

Required skills

• Extensive experience with CTIS for document uploads and/or Veeva
• Experience with CTIS and Veeva submissions

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities