Manager Regulatory Operations- Submission Sciences

    • Cambridge, MA

Job Description

The Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Acts as the primary point of contact for regulatory functions (i.e. GEM, CMC, Development, and Labelling) as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality. Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.

Principal Accountabilities:

  • Driving change, responsibility for a wide range of initiatives / relationships, as well as process efficiency / improvements.  Primary point of contact with vendor for all operational activities (e.g., allocate and track publishing, GEM operational activities, formats, templates, technical requirements).
  • Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products
  • Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets
  • Assist functional leadership to – analyzing and assess performance of vendor-related activities against defined targets (e.g. collect and measure KPIs, performance metrics data). Driving new concepts for analyzing data / promoting awareness of Regulatory Information Management strategies.
  • Internal influencing, socializing and communication of changes.
  • Driver of quality of submission build, set submission standards and ensure vendor compliance with standards.
  • Responsible for understanding and communicating impact of Industry / Agency changes relevant to submission sciences, in partnership with vendor and driving innovative process change for improved efficiency.

Qualifications

  • Bachelor’s Degree (life sciences preferable, IT/Business acceptable)

  • 4+ years pharmaceutical and regulatory experience (biotech products preferred) with 2 to 4+ years regulatory operations experience.

  • Strong communication and project management abilities in global and virtual teams

  • SME in regulatory operations processes

  • Vendor management experience beneficial

  • SME in eCTD

  • Project management qualification preferable

Additional Information

Position is based in Cambridge, MA.


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