Regulatory Affairs Professional
We are seeking a seasoned Regulatory Affairs professional to join our team. The ideal candidate will have expertise in navigating complex regulatory landscapes, ensuring the success of clinical trials.
This role is responsible for leading submissions to regulatory authorities, coordinating with ethics committees across EMEA, Asia Pacific, and Latin America, and ensuring compliance with evolving regulations.
* Key Responsibilities:
* Review study budgets and participate in business development activities
* Coordinate and manage regulatory and ethics committee submissions
* Provide expert regulatory advice and contribute to regulatory project work
Requirements:
* Candidates must have a minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
* Alternatively, a two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years experience within clinical research
* A minimum of 5 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
Benefits:
* A global team of over 3,500+ experts, bright thinkers, dreamers and doers
* A diverse and inclusive environment that promotes collaboration and creativity
* A commitment to enabling professionals from all backgrounds and experiences to succeed
About Us:
* We are a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe
* Our mission is to work with passion and purpose every day to improve lives
Contact Information:
* To view our other roles, check out our careers page
* For more information on us, visit our website