Senior Regulatory Affairs Specialist

We are looking for a passionate, resilient, and inspiring individual to join our team. As the Senior Regulatory Affairs Specialist, you will contribute to drug development, as part of the Strategic Regulatory Services (SRS) Regulatory Affairs team through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing application and post approval activities. 

In addition, we require an individual expert in the new EU CTR, with a master trainer level knowledge of CTIS that is capable of leading a CTIS Team.

Job Description

As member of the Regulatory Affairs team, you will contribute to at least one of the following activities, working under established procedures and mainly under supervision, however with the ability to work independently for routine activities and submissions :

• Contribute as EU CTR Subject Matter Expert
• Support CTIS activities and lead CTIS Team
• Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, orphan designation or PIP
• Contribute to more complex projects (early development, MAA/NDA, Post Marketing) contributing to (for example) review and compilation of documents for Scientific advice/variations/MAA, document product label review, translation requirements, fee requirements and payments, submission planning
• Support Regulatory Intelligence
• Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within Strategic Regulatory Services (SRS)
• Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
• Support to more senior team members on more complex projects
• Undertake all required tasks requested to meet departmental and project goals, as appropriate
• Participate in regulatory and/or clinical trial project teams as required.
• Responsible for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders.
• Identify department process and procedure improvements and assist in implementation of continuous improvement measures to ensure department expertise and to meet department's goals.
• Identify issues, proactively seek advice and address them in a timely manner, including development of preventative actions (as necessary under supervision)
• Assist in review or update of existing department standard operating procedures
• Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
• Maintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.