Regulatory Affairs Specialist
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
MAPI (an
ICON plc company) is currently recruiting for a Regulatory Affairs Specialist
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.
The
Regulatory Affairs Associate has responsibility for providing comprehensive
regulatory services to clients within the pharmaceutical, biologic, medical
device or other regulatory service environment. This will include support for
assessment, registration, maintenance and other activities as
assigned. This position mainly involves working with Health Canada
submissions.
The primarily responsibilities of this job include:
·
Supports Manager/Directors/project teams in the preparation of all
Health Canada submission types (e.g. NDS/SNDS/DIN/ NHP PLA) in adherence with
applicable legislation, regulations and guidelines facilitating approvals and
continued client compliance.
·
Maintains a positive and productive liaison with internal and external
contacts. This may include clients, regulatory agencies, and related
institutions.
·
Attends formal interactions (face-to-face meetings, teleconferences etc)
with clients, and possibly, government agencies. Builds positive
working relationships with clients.
·
Supports the development of initial or alternative strategies,
consulting with their manager or other resources within the
organization. Assist in identification of project issues.
·
Responsible for supporting project workflow, including prioritizing project
objectives for smaller projects and portions of larger projects, and
establishing timeframes for projects with guidance from Manager/Director/senior
team members.
·
Responsible for overseeing progress and completion of their own projects
and sub-projects ensuring timeframes and deadlines are met
·
Supports submission approvals through effective communication with
project team and client.
·
Reviews applicable client source documents to ensure they are consistent
and editorially correct
·
Maintains a cooperative and respectful working
environment. Is available as an internal resource for peers,
advising on regulatory issues and strategies
·
Ability to work off site at client occasionally may be needed.
·
Supports business operations by completing other appropriate duties as
assigned by line manager
Required experience:
·
Minimum of BSc in Life Science, healthcare, engineering preferred;
post-graduate program in Regulatory Affairs (e.g. from Humber or Seneca)
preferred.
·
Minimum of 2 years of relevant regulatory experience.
·
Understanding of local Health Authority regulations, guidelines,
policies.
·
Ability to maintain a high level of accuracy and attention to detail.
·
Effective project management skills.
·
Excellent planning, organization, interpersonal, time and change
management skills.
·
Highly self-motivated and proactive.
·
Ability to work independently and in teams as needed.
·
Proficiency in MS-Office applications including Microsoft Word, Excel
and PowerPoint
·
Communication, verbal and written: able to convey thoughts in a clear,
concise and accurate manner; use appropriate regulatory medical and scientific
nomenclature; listen carefully and ask questions when necessary to ensure
understanding; proactively share experience/expertise with others
·
Attention to detail: identifies and resolves discrepancies across
various source documents including published and unpublished documents; note
and resolve errors in written documentation
·
Planning and organizing ability: plans work effectively to
meet goals and ensure timely completion of assignments; manages time
effectively, using a system for completing work; consistently meets timelines
and works within budget; proactively discusses workload issues with
manager.
Benefits of Working in ICON
Other than
working with a great team of smart and energetic people, we also offer a very
competitive benefits package. This varies from country to country so a
dedicated recruiter will discuss this with you at interview stage.
We care
about our people as they are the key to our success. We provide an open and
friendly work environment where we empower people and provide them with
opportunities to develop their long term career.
What’s Next?
Following
your application you will be contacted by one of our dedicated recruiters and
if successful we will be able to provide you with more details about this
opportunity.
ICON is an equal opportunity
employer - Minorities/Females/Disabled/Veterans and committed to providing a
workplace free of any discrimination or harassment.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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