Associate Director, Global Regulatory Affairs - CMC

Associate Director, Global Regulatory Affairs - CMC

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:

Essential Functions

  • Planning and co-ordination of the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), as assigned;
  • Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products and/or, late, and early stage development programs. Solves unique and complex problems that have a broad impact on the function and/or broader department;
  • Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues;
  • Interpret complex technical or supply issues for commercial or development programs for the Global Regulatory Team;
  • Regularly interacts with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions;
  • Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met;
  • Contributes to the development of functional and/or broader department strategy and to departmental plans, including planning, staffing, budgeting and/or prioritization;
  • Identify and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team;
  • Monitor EU and US CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines;
  • Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products;
  • Ensure compliance with company policies, procedures and training expectations.

Required Knowledge, Skills, and Abilities

  • Demonstrated understanding and strategic application of regulations and guidelines for drug development and commercial supply;
  • Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions;
  • Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs);
  • Demonstrated understanding of FDA, EMA and ICH guidelines;
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators;
  • Demonstrated ability to influence and impact their functional area and department practices.

Required/Preferred Education and Licenses

  • BSc/BA with a minimum of eight years of regulatory CMC experience;
  • English language - written and verbal communication skills.

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© EuroJobsites 2019

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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