Regulatory Affairs Manager III

  • location: Cambridge, MA
  • type: Contract
  • salary: $78.76 - $92.66 per hour
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job description

Regulatory Affairs Manager III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

location: Cambridge, Massachusetts
job type: Contract
salary: $78.76 - 92.66 per hour
work hours: 9 to 5
education: Bachelors
The Sr. Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. The role of the Senior Delivery Manager will be increased in scope and complexity dependent on the nature and number of the products assigned. Senior Delivery Managers will be able to take on more complex cross portfolio projects / initiatives.Acts as the primary point of contact for regulatory functions (i.e. GEM, CMC, Development, and Labeling) 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.

  • 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.
  • Reviews final submission for technical quality before dispatch
  • Decide on activity prioritization and provide input to determine quality standards for vendor
  • Decide on relevance and assess impact of industry/HA changes with respect to submission sciences processes
  • Vendor coordination across multiple activities within assigned programs and varying global submission types resulting in complexity and prioritization needs on a daily basis
  • Internal coordination of deliverables requiring oversight of moving timelines, communication and multiple functional areas.
  • Ensuring partnership between Biogen and Vendor(s) delivers the quality of submission deliverables as detailed and measured by KPIs and SLAs
  • 3 years of experience
skills: CMC, Regulatory Affairs Operations, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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