The Submission Manager - Sr. Specialist is responsible for the planning, publishing (paper, NeES, eCTD), review and delivery of regulatory submissions to global Health Authorities within required timeframes. The primary accountability for this role is focused on the lifecycle submissions portfolio, but there is additional support for major/complex submissions. The Submissions Sr. Specialist also represents GRO in special initiatives, process design and validation testing of new and upgraded software.
- Primarily responsible for the planning and publishing of the lifecycle submissions portfolio, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
- Liaise with GRA and R&D authoring groups to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards. Manage deliverable and submission timelines to ensure on-time delivery to regional markets.
- Collaborate with GRO submission teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Shire's business needs.
- Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented internally.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues
- Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
- Define and implement regional and global processes for paper and electronic submission publishing, including the evaluation of current processes.
- Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
- Review R&D documents to ensure compliance with Shire's submission ready standards guidelines.
- Contribute to new and updated process and standards.
- Participate in validation testing and requirements gathering of new and upgraded software.
- Responsible for the accuracy of information for submission-related metrics for senior management.
- Participate in GRA special initiatives.
Education and Experience
- Bachelor's degree or equivalent work experience is required. Scientific and/or computer science field preferred.
- 3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.