Regulatory Affairs Specialist in Icon Clinical Research
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
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Regulatory Affairs Specialist
As Regulatory Specialist, you will work in Global Regulatory Affairs team, a successful and driven team that provides consultancy for all ICON projects globally as well as stand-alone contracts with clients. Your duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics regulatory affairs but may be in other related areas. You will be able to able to evaluate complex data and be a team player.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
Effectively contribute to all the aspects of allocated projects in timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Directors.
Participate in regulatory and/or clinical trials project teams as required.
Initiate research and regulatory intelligence in support of designated regulatory activities as required, and provide information on regulatory requirements.
As a member of the Regulatory submissions team, you will be involved in (but not limited to) the following activities:
· Preparation, compilation and submission of CTA/IND, including core document review
· Involvement in MAA/NDA projects, Variations/Lifecycle submissions, DSUR, PSUR, Renewals, Agency briefing documentation
· Management and implementation of label reviews, translation requirements, fee requirements for regulatory submissions.
· Input to regulatory Intelligence function
· Readability testing
· IMPD/IB Core Doc review, labelling review for Clinical Trials Applications
May support business development activities.
May work either as a part of the Regulatory Submissions team or a part of a regulatory or cross functional team depending on the size and nature of project.
Experience and Qualification:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Prior relevant experience in regulatory affairs or aligned work in Pharmaceutical/ Pharmaceutical contract service industry.
Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Excellent written and communication skills
Good written and spoken English.
Proficient in the use of Microsoft Office.
Bachelor’s degree, or local equivalent, in the sciences, or equivalent experience qualification.
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.
Location: Ireland-Dublin; UK-Marlow; UK-Oxford; India-Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 31st December, 2014
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