Associate Director Regulatory Submissions Management

Associate Director Regulatory Submissions Management

We are looking for an Associate Director of Regulatory Submissions Management to establish the company’s submission management function and lead submissions for upcoming global filings. This company has two major partnerships, two marketed products and a solid future where you will be able to build your career. You will work closely with cross functional teams to manage submission timelines and ensure high quality submissions. You should be solutions-oriented, analytical, and have a high level of intellectual curiosity as it pertains to regulatory development.

 

Responsibilities:

  • Assist Regulatory CMC and Clinical Strategists with global regulatory filings
  • Establish and maintain submission plans, associated timelines and run tactical submission team meetings
  • Work with program teams to formulate submission plans, including timelines and deliverables
  • Plan and conduct submission team meetings
  • Act as interface with project teams to ensure that timelines and document requirements are mutually understood and in line with Ironwood and health authority standards
  • Contribute to the development of submission processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions

 

Knowledge and Skills:

  • Minimum BA required, advanced degree preferred
  • Minimum of 5 years of regulatory experience in pharmaceutical industry
  • Experience preparing regulatory submissions in eCTD format (including NDAs/BLAs, sNDAs, INDs, CTAs, DSURs, annual reports, meeting packages) and managing projects
  • Ability to coordinate regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication
  • Must have a solid understanding of FDA regulations and ICH guidance’s
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks
  • Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups
  • Project Management certification a plus

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