SRG are looking for x3 Regulatory Senior Manager's (CTA) on 12 month contracts.
Our client a Global Pharmaceutical Company have opened 3 new vacancies within their Regulatory team who are looking to recruit x3 "Senior Manager - CTA" on an initial 12 Month contract. This role will be flexible working location starting ASAP.
The Senior Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. You may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
- Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographie
- Key participant and member of development teams and 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 Study Management, regarding essential core documents that cross both HA and EC submission and translation processes
- Prepare, review and submit 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
- Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR).
- Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements
- Coordinates submission production and assists with definition, development, and implementation of global submissions policies and technologies to meet evolving business needs.
- 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.
- Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners,
- Promotes professional development through mentoring and motivating colleagues.
- Drives connectivity and implements refinements in the Emerging Markets partner model through collaboration with peers
- Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
- Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanour
- Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
- Leads the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
- Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Departmen
- Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently
- Drives communication and proposes refinements in the Emerging Markets partner model through collaboration with stakeholders and regulatory leaders
- Leads Lessons Learned sessions and implements change in partnership with Dossier Excellence Team
- Contributes to changes in policies and strategies to meet evolving business needs
- Self-initiates assignments, developing innovative ideas to resolve complex problems and leading the execution of projects
- BSc is in Pharmacy, Life Sciences
- In-depth understanding and proven execution of CTA processes globally
- Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
- Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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