CTA Submissions Manager
An internationally renowned pharmaceutical organisation is seeking to hire a CTA Submissions Manager for their office in the UK. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.
- Driving global submission management activities for their assigned assets.
- Partnering with product teams and/or third-party partners, taking responsibility for representation and management of required regulatory activities, standards, and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
- Advocating realistic deliverable timelines, understanding project strategy, and assessing associated impact and present status of global submission delivery activities.
- Supporting and leading global team efforts to ensure high quality components and submissions that are compliant with format, agency, and industry guidelines, along with regulatory strategies, policies, and timelines.
- Liaising with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes.
- Preparing, reviewing, and submitting submissions to HA/Regional CTA Hub, in order to obtain all necessary authorisations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission.
- Managing the compilation for core package build, contributing to CTA, and authoring documentation as required.
- Acting as Subject Matter Expert for Regulatory Operations and providing country-level intelligence on clinical trial regulatory (CTR).
- Ensuring 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.
- Coordinating submission production and assisting with the definition, development, and implementation of global submissions policies and technologies to meet evolving business needs.
- Escalating, informing, and resolving any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- Serving 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.
- Promoting professional development through mentoring and motivating colleagues.
- Driving connectivity and implementing refinements in the Emerging Markets partner model through collaboration with peers.
- Promoting 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.
- Operating as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
Skills and Requirements:
- 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 processes globally.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive.
- Understanding of EU Clinical Trial Regulation Desirable.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
- Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications, and submissions management.
- An 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.
- Significant knowledge of the drug development process, Regulatory Affairs, and submissions management.
- Demonstrable understanding of regional and national regulator filing guidelines and dossier requirements.
- Advanced knowledge of the processes, systems and regulatory guidance and a detailed understanding/knowledge of principles and concepts of other disciplines.
- Proven ability to embrace new technologies and processes and drive their implementation Qualifications (i.e., preferred education, experience, attributes).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emily Oakley-Keenan at +44 2038542469 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.