Global Regulatory Submission Manager Job

GLOBAL REGULATORY SUBMISSION MANAGER needed for a CONTRACT opportunity with Yoh's client located in RESEARCH TRIANGLE PARK, NC.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Regulatory submissions
- Project Management

WHAT YOU'LL BE DOING:

- Project manage the preparation and on-time delivery of major submissions to global Regulatory Authorities for Pharma and/or Biologic applications, such as: NDAs, BLAs, MAAs, International (IRFs, Asean CTDs, iCTDs), including major supplements, line extensions, and label updates.
- Develop and manage detailed project plans (using Microsoft Project) for major submissions in key markets in which client does business.
- Ensure that applications and dossiers are prepared in compliance with Regulatory Authority regulations and guidances and with SOPs and working practices.
- The job holder works with global submission teams and third parties to project manage major applications from submission through to approval, leading discussion of deliverables and timings, facilitating scenario planning, performing impact analysis, and working with various project planning software to create submission timelines, Gantt charts, status reports, etc.
- The job holder will utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated systems and project management software to ensure high quality and timely submissions.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelors degree in science related field
- Knowledge of NDAs, BLAs, MAAs, International (IRFs, Asean CTDs, iCTDs), including major supplements, line extensions, and label updates.
- Regulatory submissions experience
- Project management experience

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayPROF

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