Regulatory Affairs Manager

1 tydzień temu

Warszawa, Mazovia, Polska IQVIA Pełny etat

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.

To our lifecycle management team we are looking for Regulatory Affairs Manager that will support activities on the Russian market. This is an individual contributor role that requires native/fluent Russian language knowledge and solid experience in post-approval regulatory affairs in Russia.

Main Responsibilities

  • Acts as a Regulatory Lead on complex projects, which may include technical writing or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
  • Competently writes regulatory and technical documents with minimal review by senior staff.
  • Establishes relationships with customers and stakeholders; may meet face to face without the rest of the team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
  • Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized and challenges when appropriate.
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
  • May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at the discretion of senior staff.
  • May write new regulatory standard operating procedures, and propose revisions or act as reviewer for regulatory standard operating procedures.
  • Manages meetings with Regulatory Agencies.

Qualifications

  • Bachelor's or Master's Degree in Life Science or related discipline
  • At least 5 years relevant experience in lifecycle management regulatory affairs for the Russian market
  • Native (preferred) or fluent in Russian language
  • Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
  • Expert in planning and delivering work on time while keeping quality parameters in mind.
  • In-depth knowledge of regulatory procedures and intelligence in Russia
  • Ability to work closely with client regional heads to determine the Regulatory, Publishing & submission strategy and execute project plan.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Strong software and computer skills, including Microsoft Office, publishing applications, and tools, as applicable.
  • Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, CMC and publishing projects.
  • Project leadership experience.
  • Ability to adapt quickly to a rapidly changing environment.
  • Russian language at level C1 and above
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