Senior Manager, Regulatory Affairs - IVD

Senior Manager, Regulatory Affairs - IVD

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence.

Location : US Remote, Portland, OR area preferred

We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing :

• 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).
• Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
• Contribute to at least two of the following areas : interactions with regulatory agencies, early phase consulting, development planning (PDP / RDP / CDP), scientific / agency advice, orphan drugs / pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support / GCP compliance, biological / biotech / biosimilars, small company support (incl. SOPs development etc.).

Your profile :

What ICON can offer you :

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include :