Regulatory Cta Submission Manager

il y a 6 jours

Eu, France Icon plc Temps plein

**Overview**:
**Regulatory affairs CTA submission Manager - Homebased in Ukraine Only**:

- An exciting new role with ICON within our regulatory team working on high profile Pharma projects with a client with which ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market.
The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs.
- They may operate as regulatory operational Subject Matter Expert for EU CTR and drive submission teams towards the timely delivery of globally compliant submission-ready components.

THis role requires:

- Strong country experience in Ukraine with the ablity to perform local paper submissions if needed

**Responsibilities**:
**Role Responsibilities**
- Drives regional submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and support 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
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- CTA Manager may act as local country liaison when required
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

**Qualifications**:

- 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 regionally
- Must have experience in EU CTR
- Hands on submission experience using CTIS
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- #LI-PH1

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