Regulatory submission manager
ICON plc · Warsaw
Regulatory submission managerICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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.
Visit our careers site to read more about the benefits ICON offers.
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 here.
Are you a current ICON Employee? Please click here to apply