Regulatory Affairs Strategist
A well-known international pharmaceutical company with sites around the globe is looking to hire a Regulatory Affairs Strategist. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- Providing an interface to Regulatory and GPD partners within designated Business Units.
- Offering project leadership and expertise in the logistics involved with the execution of regulatory CTA submissions to regional partners and selected Health Authorities.
- Working with contributing business lines to lead operational submissions execution for designated CTAs.
- Operating as regulatory operational Subject Matter Expert for a CTA and driving submission teams towards the timely delivery of globally compliant submission-ready components.
- Driving global submission management activities for their assigned assets.
- Partnering 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 geographies.
- Supporting and leading global team efforts to ensure high-quality components and submissions that are compliant with industry, agency and format guidelines, 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.
- Co-ordinating 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 provides 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 assists with 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.
- Driving connectivity and implements 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.
- Leading the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at a global and local level.
- Managing time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Department.
- Providing guidance to and leading CTA submissions and process improvement projects, making decisions independently.
Skills and Requirements:
- B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology. Equivalent relevant professional experience will be considered.
- Proven ability to embrace new technologies and processes and drive their implementation Qualifications (i.e. preferred education, experience, attributes).
- 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.
- Proven aptitude in leadership, problem-solving and logistics.
- Ability to work on multiple highly complex projects simultaneously.
- Demonstrating attention to detail.
- 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.
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 Numhom Sudsok at 0203 871 8093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.