Provide regulatory leadership, strategy and tactical support for assigned investigational projects; represent Regulatory Affairs on global project development teams; remain current on global regulatory requirements, with attention to US and Canada; demonstrate excellent interpersonal skills and the ability to lead multiple tasks.
Regional Regulatory Leader (RRL) on assigned products.
Support Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
Lead developing and creating regional regulatory strategies for multiple clinical development projects and marketed products at all lifecycle stages (Phase I through post-marketing).
Author and / or review regulatory documents for submission to US and/or other Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs, orphan, etc).
Provide leadership and strategic input to the Filing Submission Team and lead other project sub-teams, as assigned.
Lead the preparation for and conduct of formal meetings with regulatory health authorities including the review of applications and negotiations with Health Authorities.
Create and maintain Regional Regulatory Strategies and input into the Global Regulatory Strategic Document.
Identify and escalate potential Regulatory issues to management and propose risk evaluations and mitigation strategies.
Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
Research regulatory requirements to support submissions or inquiries from functional groups.
Remain current on changes in regulatory requirements and environment, and be a resource to functional groups for regulatory information.
Bachelor’s degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, Pharm D, MD) is preferred.
3-5 years of direct regulatory affairs experience, including the leading of Health Authority meetings and supporting submission of marketing applications in the US/ Canada.
Standard computer proficiency
Strong written and oral communication skills and the ability to interact effectively with cross-functional project teams.
Ability to manage regulatory affairs activities and provide leadership in a “hands-on fashion” while utilizing a strategic approach in all aspects of global development and compliance.
This position may require up to a minimum of 10% domestic and international travel.
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About Kyowa Kirin
The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around
the world by creating new value through the pursuit of advances in life sciences and technologies.
Our goal is clear: to do everything we can to answer the unmet medical needs of patients, their families, and
medical professionals, and to do it as quickly as possible. Because every moment counts.