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Senior Regulatory Affairs Manager - Global Expansion

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

The senior manager for global expansion ROW, will be responsible for leading cross-functional teams for new ROW registrations, as well as managing the on-going life-cycle maintenance activities for assigned products covering ROW markets. Regulatory filing and life-cycle maintenance activities will also be coordinated in collaboration with in-country partners.

The individual is responsible for executing the regional regulatory strategy pertaining to the

development, registration and regulatory compliance of Jazz products in the ROW markets as

dictated by Jazz business objectives. This will include interacting with the relevant groups as

needed to ensure timely submission and approval for Jazz products in these markets

Essential Functions

  • Provide regulatory support and expertise for the ROW (AsiaPac, LATAM, MENA) portfolio of products
  • Ensure ROW filing strategy is appropriately represented within the Global Regulatory Team (GRT) and at other appropriate forums (Global Development Team etc.)
  • Lead and manage more junior roles, as required



Required Knowledge, Skills, and Abilities

  • Minimum of 7 years' experience in the pharmaceutical industry, with minimum of 5 years direct experience in ROW registration activities
  • Planning & management of all allocated projects and ensuring timely delivery of these projects
  • Collaborate with cross-functional team to develop and implement regulatory strategies based on organisational priorities and resource availability
  • Ability to work cross-functionally and in collaboration with key internal stakeholders/customers (e.g. commercial, technical, quality, medical, supply chain etc.)
  • Working knowledge of regulatory requirements and cultural differences for various country registrations and maintenance activities (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies)
  • In addition to working in cross-functional teams, must also be able to work successfully as an individual contributor, with a high level of professionalism
  • Proven experience in regulatory affairs with particular focus on initiating and managing new ROW registrations and life-cycle maintenance activities (e.g. Variation applications including new indications, Renewals, PSUR submissions, Notifications, MA transfers, MA cancellations)
  • Act as contact point/knowledge base for scientific & technical aspects of Module 1 documents and associated regulatory activities
  • Ensure compliance with product post-marketing approval requirements
  • Timely filing of complete, high quality regulatory submissions; prompt, complete and accurate management of responses to Health Authority questions and effective communication of approvals
  • Ensure that all submissions comply with the current regulatory guidelines and legislation at all times. Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Ensure 100% accurate and complete archiving of all submissions, approvals and regulatory agency correspondence performed in ROW markets. Ensuring that regulatory document management system contains the most current and accurate information
  • Excellent verbal and written communication skills and collaborative interpersonal skills.
  • Ability to travel occasionally - approximately 10-20% regional and/or international travel
  • Responsibilities may require working outside of "normal" hours, in order to meet business demands



Required/Preferred Education and Licenses

  • Bachelor's degree required (Scientific discipline preferred) or equivalent in industry related experience



Jazz Pharmaceuticals is an Equal Opportunity Employer.

Senior Regulatory Affairs Manager - Global Expansion

Oxford, UK
Full Time

Published on 03/17/2020