An internationally renowned pharmaceutical company is currently advertising a Regulatory Clinical Trial Application Submission Manager to their office in London. This top 10 pharma company works across multiple sectors, including medical devices, pharmaceutical research, and consumer health. The vacancy offers an exciting opportunity to work with a company with over 100,000 professionals around the globe.
The Regulatory Clinical Trial Application Submission Manager will be responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development, and registration of products. Depending on the particular project and assigned submission(s), required activities may include establishing Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products.
Job Responsibilities:
- Generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
- Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
- Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
- Support development of departmental work practices, process enhancements, and associated training materials.
- Develop/maintain associated process tools and relevant training documentation. Support compliance needs as appropriate.
- Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements.
- Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission.
- Participate on special projects and process improvement initiatives, as needed.
Skills and Requirements:
- Bachelor's Degree or equivalent.
- A minimum of 6 years of professional experience required.
- A minimum of 3 years of Regulatory Affairs experience required.
- Experience associated with managing or publishing of global regulatory submissions, including EMA (National, MRP and CTAs), EMEA Emerging Markets, and FDA.
- Therapeutic area and product knowledge and understanding of drug development process.
- Demonstrated project or submission management capabilities preferred.
- Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines required.
- Ability to use Regulatory Information systems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
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 Peter Duvall at +44 203 078 9542 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.
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