Director, Regulatory Operations
At ICON plc, a world-leading healthcare intelligence and clinical research organization, we foster an inclusive environment that drives innovation and excellence. We are seeking a Director, Regulatory Operations to join our diverse and dynamic team.
This role will play a pivotal part in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:
* Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
* Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
* Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
* Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
* Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
Requirements:
* Bachelor's degree in a scientific or related field; advanced degree preferred.
* 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
* Strong understanding of global regulatory requirements and guidelines.
* Proven track record of successful regulatory submissions and approvals.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
* Proven leadership experience.
About Us:
We value diversity, inclusion & belonging at ICON plc. Our rich diversity makes us more innovative, allowing us to better serve our people, patients, customers, and communities. We strive to create an inclusive and accessible environment for all candidates and employees.