Regulatory Operations Associate
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for passionate, resilient, and inspiring individuals to join our team. As the 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.
- 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.
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin