Provides project management support to ensure regulatory strategies are developed and seamlessly executed upon, enabling successful global filings with Health Authorities. Manages and supports the planning and execution of high quality regulatory submissions such as NDAs, BLAs, MAAs, INDs, and other US submissions (e.g. amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.) including the drafting and preparation of appropriate US forms and cover letters Primary Duties
- For assigned projects, is responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to provide project management support to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.
- Manages and provides supports with the planning and execution of high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. This includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.
- May with supervision as appropriate, function as main liaison / point of contact between FDA and company.
- Maintains up-to-date knowledge of FDA regulations/guidance documents, and ICH guidelines.
- Provide project management support for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan and deliver GRT goals and regulatory submissions.
- For assigned programs, prepare meeting agendas, meeting minutes,and together with the team prepare effective issue and risk management plans.Develop and actively manage project timelines and integrated submission project plans. Prepare and distribute reports and trackers to communicate updates and project status.
- For speficied programs, proactively drive project teams, establishing an appropriate level of urgency and keen focus on deliverables.Track Project variances and assist in the identification of root causes. Conduct lessons learned sessions to identify areas for improvement.
Education and Experience Requirements
- Plan and coordinate the delivery of US submissions, including authoring of certain M1 components (e.g. drafting of forms and cover letters).
- Coordinate and consult with GRL and other departments on the content, preparation and assembly of regulatory documentation in support of US filings. Perform final editorial checks of regulatory content prior to hand off to submission management.
- Coordinate and provide operational support for FDA meeting requests, meeting rehearsals, briefing book preparations and assist in the preparation of meeting minutes of FDA meetings.
- For specified programs, support the GRPMUS Leads with project management and tactical exection of regulatory strategy deliverables for complex programs/projects.
- Responsible for ensuring regulatory compliance for all assigned responsibilities.
- Act as a conduit of information between assigned cross-functional submission teams and the GRT.
- Work with submission management on the development of regulatory submissions.
- Support and assist in the development, implementation and continuous improvement of PM tools and processes for global regulatory project management of new product licensures and lifecycle project management for existing products.
Other Job Requirements
- BA/B.S in a scientific, healthcare or related field or equivalent experience
- 4+ years project management experience in RA or Drug Development required. 2+ years experience in Regulatory Affairs required.
- Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements
- 5-10% travel required mostly within North America.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.