Global Regulatory Operations – Regulatory Data & Analytics – Senior Associate
Amgen
Lisbon, Lisboa, PT
há 4 dias

Global Regulatory Operations Regulatory Data & Analytics Senior Associate

Job Summary :

All, or a subset of the following :

Quality :

  • Monitoring data quality / health, including collaboration with other internal functions to maintain planned submission and approval dates
  • Integrations :

  • Updating the Regulatory Submissions and Document Information Management System (RSDIMS)
  • Analytics :

  • Metrics compilation and analysis
  • Liaison with internal customers to improve efficiencies within RDA and other functional areas
  • Manages requests within the Regulatory Intake System to comply with data management of a GMP system
  • Key Activities :

  • Maintain Regulatory document management and tracking systems.
  • Create / archive Clinical Trial and Marketing Application submissions / Health Authority correspondence
  • Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming / outgoing off-site Regulatory document storage.
  • Point of contact between Regulatory Representatives / CMC and publishing teams.
  • Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates / additions.
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide training, mentoring and support to RDA team members and other functional areas, including vendors.
  • Collaboration with external partners / outsourced CROs
  • Run 1572 forms for FDA submission.
  • Knowledge and Skills :

  • Working in teams
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
  • Complex understanding of the Veeva Vault system
  • Good written and verbal communication skills
  • Detail oriented
  • Independent time management and prioritization skills
  • Work efficiently with little support and minimal to no supervision
  • Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
  • Critical thinking skills
  • Appropriate software skills as required
  • Education & Experience (Basic) :

    Master’s degree

    Bachelor’s degree and 2 years of directly related experience

    Associate’s degree and 6 years of directly related experience

    High school diploma / GED and 8 years of directly related experience

    Education & Experience (Preferred)

  • Industry experience
  • Experience in an operationally-focused role within Regulatory Affairs
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