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Project Manager, Regulatory Affairs

Project Manager, Regulatory Affairs

Veristat, , Spain, España
Hace 4 días
Descripción del trabajo

Overview

Project Manager, Regulatory Affairs at Veristat. The Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects. S\ / he interfaces with internal departments and company leadership, and externally with sponsors and vendors. The Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams.

Responsibilities

  • Provide management and leadership to plan, prepare, and execute high quality projects in the regulatory affairs domain.
  • Interface with internal departments and company leadership, and externally with sponsors and vendors.
  • Integrate consulting activities across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams.

What We Look For

  • Bachelor’s degree in life / health sciences or related discipline, or equivalent required.
  • 4 to 6 years of relevant Regulatory experience in a Clinical Research Organization / Pharmaceutical Company, with a minimum of 2 years of Project Management or functional team lead experience required.
  • Excellent written and oral communication and interpersonal skills, as well as strong planning and organizational ability.
  • Good working knowledge of the drug development process and regulatory requirements, including familiarity with ICH guidelines and other applicable regulatory rules and guidelines.
  • Proficiency in English (written and verbal).
  • Action-oriented and resilient in a fast-paced environment; ability to build effective project teams, motivate others, delegate, and make and implement decisions.
  • Ability to build and maintain trust and confidence and communicate effectively with clients, external vendors, and internal team members.
  • Automated Decision Making : All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

    Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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