Regulatory Affairs Specialist
ICON Public Limited Corporation
Position Name : Regulatory Affairs Specialist
Location : Tokyo, Japan
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
· Minimum of BS in Life Science, healthcare, engineering preferred
· Native Japanese language skill needed, High-level English needed
· 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.
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.