Sr Manager, Reg Affairs

Senior Regulatory Affairs Manager

US remote worker.

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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

As Senior Regulatory Affairs Manager, you will lead project teams and client meetings to provide regulatory strategy and guidance.

• Participate in provision of Regulatory expertise in strategic drug development across multiple areas.

• Take part in preparation of strategic development and submission plans.

• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and Internally)

• Interactions with Regulatory agencies

• As a Regulatory Expert, build effective teams and Involve junior members of the team into more complex regulatory issues.

• Mentor and train across function to support the wider Regulatory Department.

What you need

• Experience of the US regulatory landscape, dealing with the FDA.

• Minimum of a Bachelor's degree in Regulatory/Life Sciences

• Minimum of 8 years of Regulatory experience in Pharma, Biotech, or related industry

• Knowledge of IND/NDA/BLA requirements

• Sound knowledge of the life cycle of a drug development program

Why join us?

Ongoing development is vital to us, and as the Sr Regulatory Affairs Manager, you will have the opportunity to progress your career to becoming a Director working on a diverse range of therapeutic areas, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.