Regulatory Affairs Specialist

Role Responsibility

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.

Additional Responsibilities:

• 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.

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 - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.    - *LI-KT1