Senior Regulatory Affairs Specialist (Clinical Regulatory)

Sr Regulatory Affairs Specialist

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As the Sr Regulatory Affairs Specialist, you will contribute to drug development, as part of the Global 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.

The roleAs 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 :Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, China HGRA, Annual reports to IND, orphan designation or PIPContribute 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 planningSupport Regulatory IntelligencePeer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICONCommunicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as requiredSupport to more senior team members on more complex projectsUndertake all required tasks requested to meet departmental and project goals, as appropriateParticipate 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 proceduresDevelop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessaryMaintain an accurate record of the time associated with each allocated activity and ensure compliance with all timekeeping and tracking systems

What you needA minimum of a Bachelor's degree or local equivalentMinimum of 3 - 5 years in Regulatory Affairs in the Pharmaceutical industryKnowledge of clinical development, FDA, IND SubmissionsAbility to multi-task, & support various projectsBe able to solve problems in pro-active and timely mannerEncourages and initiates teamwork. Respects diversity, values the opinions of others. Leverages teams' strengths, empowers and delegates appropriately