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Clinical Trials Regulatory Manager

hace 3 meses

Buenos Aires, Argentina IQVIA A tiempo completo

ROLE PURPOSE:

Oversees intricate regulatory projects and programs while guiding less experienced team members.

RESPONSIBILITIES:

  • Serve as a Clinical Trials Regulatory Manager (CTRM) for complex clinical trial projects/programs and potentially lead Regulatory Oversight for a key customer.
  • Manage stand-alone projects as a Project Manager.
  • Review core scientific documentation administratively and technically, providing feedback and conducting gap analyses for customers.
  • Strategically plan and execute European centralized submissions and facilitate global submissions for complex studies and programs.
  • Compose scientific documents such as Investigational Medicinal Product Dossiers and clinical trial justifications.
  • Develop training materials and conduct training sessions both internally and externally.
  • Proactively identify potential challenges that may impact trials, devising strategies for optimized delivery.
  • Offer guidance to junior colleagues, actively participating in sharing knowledge within the department.
  • Support strategic regulatory business development initiatives, contributing to proposal development and client presentations.
  • Undertake additional responsibilities as assigned by the Line Manager.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

  • Solid grasp of regulations, directives, and guidance pertinent to clinical Research and Development.
  • Extensive background in regulatory and/or technical writing.
  • Proficient in negotiation and influencing, adept at issue identification and resolution with a flexible approach.
  • Demonstrate strong ownership and oversight capabilities.
  • Earn respect from peers across different operational groups.
  • Skilled in establishing and nurturing effective relationships with co-workers, managers, and clients.
  • Innovative and inclined towards solutions-oriented approaches.
  • Proficient in software and computer applications, particularly MS Office suite.
  • Set a positive example for junior colleagues regarding professionalism, positive demeanor, and communication with customers and peers.
  • Capable of taking calculated risks in decision-making, seeking guidance from Regulatory management when necessary, while demonstrating autonomy and initiative.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Degree in a life science-related field or equivalent professional qualification with a minimum of 6 years of relevant experience, with at least 4 years in regulatory affairs; alternatively, a high school diploma with 10 years of relevant experience, including 6 years in regulatory affairs (or a suitable combination of education, training, and experience).

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services for the life sciences sector. Our commitment lies in expanding the frontiers of human science and data science to drive substantial positive changes – aiding our clients in fostering a healthier world. For more information, visit