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Sr Regulatory Affairs Officer (R1057458) in Buenos Aires, Argentina at IQVIA™

Date Posted: 1/19/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/19/2019
  • Job ID:
    R1057458

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

RESPONSABILITIES

  • Lead and manage regulatory activities related to asset transfers for pharmaceutical drug products following established organizational processes and procedures.
  • Manage regulatory drug products’ maintenance projects planning, execution, and monitor & control efforts, report on progress, manage project closing as required.
  • Work with project leadership, team and other stakeholders preparing project plans and associated agreements.
  • Organize, attend and facilitate cross-functional and regulatory meetings as needed.
  • Coordinate tracking and delivery of the project strategic plans including preparation of regulatory submissions, provide status updates as required.
  • Lead and/or assist in Regulatory Risk management efforts for the assigned projects.
  • Ensure collaborative relationship with the assigned project internal and external stakeholders.
  • Responsible for timely and seamless delivery of the assigned work.
  • Assist with location of documents, ad hoc requests or communication of the project plan.
  • If assigned, lead a broad cross-functional teams.
  • If assigned, act as the Patient Safety and Regulatory Affairs lead in the cross-functional teams.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Pharmacist or Degree in life science-related discipline
  • Comprehensive expertise in Regulatory Affairs for market applications, marketed products licenses’ maintenance (e.g. renewals, transfers, CMC) and surveillance with 5 years of relevant experience in similar positions
  • Highly organized, proactive, and detail oriented
  • Experienced communicator and facilitator
  • Effective time manager with ability to work on several activities, retaining quality and timelines; able to prioritize workload
  • Proficient in standard business productivity tools (e.g. Microsoft Office package)
  • Good organization and problem-solving skills
  • Ability to establish and maintain effective working relationships with a diverse set of Global internal/external cross functional co-workers, managers and clients
  • Advance English level

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1057458