Regulatory Operations Associate

Regulatory Operations Associate

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 Regulatory Operations Associate, you will collaborate with the US regulatory team. You will be responsible for responsible for the compilation and maintenance of all US regulatory submission types in a timely and accurate manner.

The role

• Provide support for submissions assembly, and coordinating resources for submissions in a timely and accurate manner.
• Responsible for submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (electronic), and archiving (electronic), as applicable.
• Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with clients.
• Assist in the design and implementation of new processes or initiatives within the department.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.

• Participate in special projects and carry out assigned activities in support of the Publishing function.

What you need

• A minimum of a College Bachelor's degree or local equivalent
• Strong communication skills written and orally
• Strong computer skills, sound knowledge of MS Office Suite and Adobe
• Ability to multi-task, support various projects

Why join us?

Ongoing development is vital to us, and as a Regulatory Operations Associate, you will have the opportunity to progress your career, 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.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin