Regulatory submission manager

ICON Strategic Solutions; Poland; On-site; PLN 240,000 - 360,000; Full time

Benefits offered by this job

Health insurance

Competitive retirement planning

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions is seeking a Regulatory Submission Manager to lead regulatory submissions for CTAs globally. The role sits in the Regulatory Affairs team and acts as regional representative within study teams.

You will manage translation coordination, core document gathering, and cross-functional collaboration with sponsors, SSU, and study management to ensure timely, compliant submissions.

Qualifications

• Extensive experience with CTIS for document uploads and/or Veeva.
• CTA and Central Ethics processes knowledge.
• Education in Pharmacy or Life Sciences and related fields.

Responsibilities

• Drive global submission management strategy for assigned protocols and regulatory deliverables.
• Lead meetings to set realistic timelines and monitor submission status.
• Ensure high-quality submissions compliant with guidelines, policies, and timelines.
• Coordinate core documents and translations across HA and EC submission processes.

Skills

Regulatory submissions

Global coordination

Stakeholder communication

Regulatory strategy

Education

B.S./B.Sc in Pharmacy or Life Sciences

Tools

CTIS

Veeva

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.

What You Will Be Doing

• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of 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 and present status of global submission delivery activities
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
• Liaise with Sponsor Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and support Sponsor submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May be responsible for proactive processing of incoming request for information (RFIs) by daily monitoring RFI-dedicated mailbox and Clinical Trials Information System (CTIS) portal and reporting RFIs to study teams, ensuring effective communication and coordination to facilitate the smooth execution of regulatory submissions.
• May be responsible for proactive processing of payments, ensuring timely and accurate financial transactions involved in regulatory submissions.
• May act as local country liaison when required
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities
• Discuss with relevant Sponsor SMEs the interpretation of dossier requirements

Your profile

• Extensive experience with CTIS for document uploads and/or Veeva is required
• B.S./B.Sc is 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

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here