Regulatory Affairs specialist
About the role
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Hi,
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.
We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Job Title : Regulatory Specialist
Type of Employment : Full Time
Location : ICON PLC, INDIA
Responsibilities:
• Responsible for oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.
• Responsible for providing advice and support to the project team for regulatory aspects of the projects.
• Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.
• Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
• Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Regulatory Affairs activities.
• Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
• Responsible for liaising with other departments on requirements for regulatory submissions.
• May act as a Contract Specialist if appropriately trained.
• Participating in the improvement of the Quality Assurance System.
• Completing other appropriate duties, as assigned by the manager, which require similar skills in accordance with business needs
You will have:
Education to degree level
Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP or local requirements)
Proficiency with computer systems
Strong verbal and written communication skills
Strong organisational, time management, interpersonal skills.
Ability to work both independently and in a team environment.
Benefits of Working in ICON
In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.
We are more like an extended family with consideration of staff as individuals allowing a work-life balance.
You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.
If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com.
PROCESS
Technical and competency selection:
When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.
The evaluation will look at your technical skills and your competencies – for example, delivering excellence.
Interview
After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.
Offer
If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.
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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