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Regulatory Clinical Trial Application Submissions Manager

  • Job reference: 925224
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 01/05/2019

Orion Group are currently recruiting for a Regulatory Clinical Trial Application Submissions Manager on a 6 month contract basis (with potential to be extended) for our Multinational Pharmaceutical client based in High Wycombe.

Position:

  • You 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, but may not be limited to:
    Establishing Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products.

The candidate will be responsible for:

  • 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.

Qualifications:
Bachelor's Degree or equivalent experience required; 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 is required; Therapeutic area and product knowledge, understanding of drug development process preferred; Demonstrated project or submission management capabilities preferred; Demonstrated effective interpersonal, teamwork, and communication skills required; Ability to exercise solid judgment and communicate effectively with varied levels of the organization required; Ability to work in a matrix environment required; Demonstrated ability to build productive relationships across an organization required; Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines required; Problem solving capability, including trouble shooting and adaptability required; Ability to use Regulatory Information systems.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.