Alexion Pharmaceuticals - Boston, MA

posted 22 days ago

Full-time - Mid Level
Boston, MA
Chemical Manufacturing

About the position

The Regulatory Business Operations Manager at Alexion Pharmaceuticals plays a crucial role in the operational management of the Regulatory Affairs team. This position involves supporting multiple stakeholders and ensuring the effective execution of strategic initiatives, while also managing various administrative tasks essential for the department's success.

Responsibilities

  • Support the Head of Business Planning & Operations in managing and executing strategic initiatives.
  • Partner with the Administrative Lead in Dublin to meet operational needs across the organization.
  • Act as the main point of contact for all Regulatory Affairs staff to resolve issues.
  • Provide operational and administrative support for all initiatives in the US.
  • Assist teams with daily business needs, including onboarding/offboarding, event planning, and facilities management.
  • Manage onboarding and oversight of Outside Service Providers and Contingent Workers.
  • Support the maintenance of relevant data sources for the Regulatory Affairs team.
  • Assist with Organizational Development and Change Management initiatives.
  • Oversee vendor maintenance, legal/contract execution, and purchase orders.
  • Align with peers across the Enterprise to support process improvement in Regulatory Affairs.
  • Lead the development of monthly communications on behalf of the VP of Regulatory Affairs.
  • Execute quarterly town hall meetings, including presentation development and response aggregation.
  • Maintain and update the Regulatory Affairs SharePoint site.

Requirements

  • Bachelor's degree
  • 5 years of relevant experience
  • Understanding of all stages of drug development (preapproval, authorization, and post-marketing)
  • Ability to manage multiple stakeholders and build team relationships in a global environment
  • Experience in developing and implementing strategic initiatives in the pharmaceutical industry
  • Ability to manage complex issues and influence effectively in matrix organizations
  • Excellent written and verbal communication skills
  • Proficiency in Microsoft Office.
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