Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Location: Dublin, Ireland or Marlow, UK

'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 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.

The role

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 :

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

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

What you need

A minimum of a Bachelor's degree or local equivalent

Minimum of 3 - 5 years in Regulatory Affairs in the Pharmaceutical industry, EMA or European experience would be advantageous

Ability to multi-task, & support various projects

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

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.