Regulatory Operations Associate (Pusblishing)
TA Business Partner
- Full Service Division
About the role
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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
*LI-SB1
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