Sr Regulatory Affairs Specialist
Ireland, UK or Europe
Remote Working
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
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?
The role
We are looking for passionate, resilient, and inspiring individuals 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.
- As member of the Regulatory Affairs team, you will contribute to at least one of the following activities, working under established procedures and supported by Regulatory Managers/Directorsbut 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, 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 SRS
- Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
- Provide support to more senior team members on 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 (with support as necessary)
- 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
What you need
- A minimum of a Bachelor's degree or local equivalent - Life Science, healthcare, engineering preferred
- Minimum of 3 - 5 years in Regulatory Affairs in the Pharmaceutical industry, EMA or European experience would be advantageous
- Understanding of local Health Authority regulations, guidelines, policies
- Ability to multi-task, & support various projects
- Effective project management skills
- Good written and spoken English
- Proficient in the use of Microsoft office
- Ability to maintain a high level of accuracy and attention to detail
- Be able to solve problems in pro-active and timely manner
- Encourages and initiates teamwork. Respects diversity values the opinions of others. Leverages teams' strengths, empowers and delegates appropriately
- Effective project management skills
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.
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.
