Regulatory Affairs specialist

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.