Regulatory Operations Associate (Pusblishing)

ICON is currently recruiting for a Regulatory Operations Associate to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

Regulatory Operations Associate

This role is part of the Regulatory Operations group 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.

Responsibilities and Accountabilities:

·         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

Qualifications:

·         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

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment

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