Associate Director Clinical Trial Applications

Associate Director Clinical Trial Applications

Jazz Pharmaceuticals

Oxford, United Kingdom

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.

Responsibilities:

  • Provide proactive and practical regulatory affairs guidance and strategies to achieve the required authorisations for CTA's in the EU/RoW regions;
  • Participate as an active member of a multi-disciplinary clinical team to establish regulatory strategies for the clinical trial applications for the development programs;
  • Identify and communicate potential risks associated with strategy scenarios;
  • Responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial;
  • Regulatory affairs activities with particular focus on regulatory compliance for clinical trials;
  • To communicate progress and identify risks and issues arising on regulatory issues to Regulatory Affairs management and the cross-functional Development Clinical Trial Team;
  • Management and oversight of the regulatory activities with the CROs to ensure quality regulatory submissions;
  • Responsible for submission of the CTAs directly to Health Authorities, or manage and oversee the CTA submission with the CRO;
  • Identifies and proactively responds to issues, problems, or opportunities as it relates to the management of the CRO;
  • Contribute to a range of project teams, as required;
  • Manage organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines;
  • Provide in-depth reviews of protocols, reports, presentations and documents;
  • Coordinate preparation and review of clinical trial applications, amendments, responses to Agency questions;
  • Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions;
  • Manage timelines to ensure approvals are timely and development objectives are met;
  • Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies;
  • Provide risk assessments and recommendations for various regulatory scenarios;
  • Participate in the electronic review and quality verification of regulatory submissions;
  • Develop SOP’s and work instructions to ensure consistent ways of working within the regulatory department;
  • Be a focal point and lead internal audits and external GCP inspections, as appropriate.

Minimum Requirements:

  • Bachelors or Masters or advanced degree in a scientific discipline, with 8-10 years of increasingly responsible regulatory experience in the pharmaceutical industry;
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development;
  • Knowledge of Development Good Practices (GxP);
  • Excellent English verbal and written communication skills;
  • Exceptional communication, collaboration and influencing skills;
  • Leadership ability within a team environment;
  • Ability to work with limited supervision, attention to detail, set priorities to meet timelines and to motivate and influence others;
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators;
  • Knowledge of Development Good Practices (GxP);
  • Management of more junior staff may be required;
  • Some travel may be required.

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© EuroJobsites 2019

EuroJobsites is a UK 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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