Regulatory Affairs Specialist
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
ICON 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
The primarily
responsibilities of this job include:
· Supports Manager/Directors/project teams in the
preparation of all submission types in adherence with applicable legislation,
regulations and guidelines facilitating approvals and continued client
compliance. Monitoring and managing project-specific email accounts, incoming
faxes and telephone calls. Preliminary triaging of ICSRs to determine
classification, priorities and time frames for subsequent activities.
· 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.
· Assists in the development of assessments and
strategic regulatory plans for client product development programs
· 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, travel 5-10% may be required. Passport is required
· Supports business operations by completing other
appropriate duties as assigned by line manager
Required experience:
· Minimum of BS in Life Science, healthcare,
engineering preferred
· Minimum of 2 years of relevant experience, i.e.
medical device with regulatory experience in the local environment.
· Understanding of local Health Authority regulations,
guidelines, policies
· Ability to maintain a high level of accuracy and
attention to detail
· Effective project management skills
· Awareness of business development process
· Growing problem solving, judgment and
decision-making skills to seek creative solutions to issues surrounding
on-time, on-budget and high quality project outcomes.
· Excellent planning, organization, interpersonal,
time and change management skills.
· Highly self-motivated and proactive
· Ability to work independently
· 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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