At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, where you are encouraged to fulfil your sense of purpose and drive lasting change.

Role:

The Senior Consultant will be responsible to lead the regulatory strategy to support registration in Europe and internationally for drugs, and biologics and additionally be responsible for the strategic approach to securing new business, facilitating issue resolution, ensuring project and program timelines and budgets are met. You will also maintain client relationships to support of future business as the position participates in business development activities.

Key skills and knowledge:

• Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines.
• Effective project management skills.
• Through knowledge of budgetary and financial management (budget, development, time and cost, forecasting, revenue, margin, profit and loss, invoicing, etc.).
• Knowledge of business development process.
• Ability to develop and maintain excellent rapport with clients.
• Demonstrable good problem solving, judgement, and decision-making skills to motivate staff to seek creative solutions to issues surrounding timely, on-budget, and quality delivery. Focuses on resolving problems and makes decisions in a timely manner.
• Ability to make decisions independently and operate autonomously.
• Shown ability to understand, and communicate corporate policies and procedures.

To be successful, you will need:

• BSc in a relevant discipline, preferably in a life sciences, or other healthcare field.
• Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
• Relevant experience i.e. pharmaceutical, biologics, medical device with regulatory experience in the local environment (Europe).
• Experience supporting business development activities and people management an asset.
• Experience presenting at applicable industry conferences and/or publications in regulatory affairs.

Benefits of Working in ICON:

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.