Sr Regulatory Operations Associate
4d ago

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation : Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.

In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Senior Regulatory Operations Associate

Chennai, India

We are looking for passionate, resilient, and inspiring individuals to join our team. As the Sr Regulatory Operations Associate , you will be responsible for publishing, compilation, filing and maintenance of all global regulatory submission types in a timely and accurate manner.

This position may function within a project team and may interact directly with internal staff, the client, and regulatory agencies to manage compilation of regulatory submissions.

Key responsibilities :

  • Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions
  • Responsible for all aspects of publishing submissions and / or submission components for internal review and signoff, and for submission to regulatory authorities.
  • This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicable

  • Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
  • Maintain submission components associated with a regulatory submission, paper and / or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
  • Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS / publishing software
  • Perform quality review of Regulatory Operations team members work to ensure accuracy
  • Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required
  • What you need :

  • B.Sc. or related degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training.
  • RAC certification an asset

  • 3-5 years' pharmaceutical regulatory industry / regulatory operations experience
  • Experience working with current eCTD standards preferred
  • Understanding of applicable regulations and guidelines documents
  • Why join us?

    Ongoing development is vital to us, and as a Regulatory Operations Associate you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.

    Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

    Benefits of Working in ICON :

    Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

    We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.

    Our annual bonuses reflect delivery of performance goals - both ours and yours.

    We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

    But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

    ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

    All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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