[Hiring] Regulatory Submission Manager @ICON plc

Role Description

As a Regulatory submission manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team. This position serves as the regional regulatory representative within study teams, responsible for leading operational submissions execution for designated CTAs. This role requires essential experience within CTIS and VEEVA submissions.

• Drive global submission management strategy and activities for assigned protocols.
• Partner with study teams, managing required regulatory activities, standards, and deliverables associated with CTA submission development.
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact.
• Support and lead global team efforts to ensure high quality components and submissions compliant with industry, agency, and format guidelines.
• Liaise with Sponsor Core team, SSU, and Study Management regarding essential core documents and local documentation.
• Prepare, review, and support Sponsor submissions to HA/Regional CTA Hub for necessary authorizations/approvals.
• Coordinate translations for core documents required for submission.
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required.
• Proactively process incoming requests for information (RFIs) by monitoring RFI-dedicated mailbox and CTIS portal.
• Proactively process payments, ensuring timely and accurate financial transactions involved in regulatory submissions.
• Act as local country liaison when required.
• Escalate, inform, and resolve any issues impacting submission builds or logistics of global submission delivery.
• Discuss with relevant Sponsor SMEs the interpretation of dossier requirements.

Qualifications

• Extensive experience with CTIS for document uploads and/or Veeva is required.
• B.S./B.Sc 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 and use new software, regulations, and quality standards.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• 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 wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.