Associate Director, Regulatory Europe, RWLP

Associate Director, Regulatory Europe, RWLP

Premier Research

Italy

The Associate Director, Regulatory Affairs is responsible for developing, implementing and leading both regional and international strategy for assigned projects with various cross-functional teams. This role executes regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development and post approval and addresses the analysis and evaluation of regulatory procedures and changes to ensure attainment of corporate goals. The Associate Director provides guidance for, and may actively contribute to, the development of documents for regulatory agencies e.g. Investigational New Drug applications (INDs)/Investigational Medicinal Product Dossiers (IMPDs)/Clinical Trial Applications (CTAs), and New Drug Applications (NDAs)/Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs) ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. This position may supervise or manage others within the Regulatory Affairs skill group.

You'll be doing

  • Develop and execute international and regional strategies and contingencies for assigned projects;
  • Provide guidance to and supervise both international and regional regulatory teams on assigned projects;
  • Develop and implement creative approaches to ensure regulatory success;
  • Provide efficient and effective Regulatory representation across the organization and interact with the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies;
  • Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and support NDAs/BLAs/MAAs;
  • Coordinate with cross-functional teams to define contributions to submissions;
  • Think ‘analytically and strategically’ and convey complex concepts in an understandable manner;
  • On assigned projects, lead regulatory for submission teams;
  • Interface with international affiliates on regional regulatory strategy and implementation plans;
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines;
  • Conduct business development efforts;
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures;
  • Effectively communicate comments/recommendations and proactively engage program teams to establish solutions to issues;
  • Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group;
  • Review and approve timesheets and expense reports and guide the performance of assigned staff.

You'll Need

  • Bachelor’s degree, or international equivalent from an accredited institution, in a science or health related field; PhD preferred;
  • 10+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry; an advanced degree will be considered in lieu of a portion of industry experience;
  • 7-9 years progressive regulatory affairs experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company;
  • 5-6 years supervisory/management experience;
  • Demonstrated experience interacting with the Food and Drug Administration (FDA) required, experience with other regulatory agencies preferred;
  • Demonstrated experience in the establishment of INDs and supporting approvals of NDAs/BLAs/MAAs;
  • Results driven and team-oriented, with the ability to influence outcomes as necessary;
  • Able to innovate, analyze, and solve problems with minimal supervision;
  • Exceptionally keen attention to detail;
  • Demonstrated ability to manage a staff to achieve company and client goals.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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