Director, Regulatory Affairs Strategy- Oncology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, Regulatory Affairs Strategy provides global leadership in Regulatory Affairs, offering both strategic and tactical support for oncology therapeutic development assets. This role involves representing Regulatory Affairs on global project development teams ensuring alignment with regulatory requirements and advancing the development of Kyowa Kirin assets with an emphasis on oncology therapies.

Essential Functions:

Global/Regional Regulatory Leader on assigned Products
* Lead/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 development and creation of global/regional regulatory strategies for multiple clinical development projects at all stages (Phase I through market authorization).
* Author and / or review regulatory documents for submission to US/Canada, and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs / NDSs / MAAs, orphan designation, etc.).
* Provide oversight of external partners and deliverables to ensure compliance with regulatory requirements and alignment with global regulatory strategy.
* 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 Health Authority meetings with KKNA Regional Regulatory Lead including the review of applications and negotiations with Health Authorities.
* Provide regulatory expertise, advice, and requirements for pre-clinical and clinical disciplines, in support of drug candidates under development either on project teams or management committees.
* Create and maintain Regulatory Strategic Development plans and provide strategic input to global project development plans.
* Identify and escalate potential regulatory issues to executive 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.
* Prepare and review SOPs / WIs to achieve consistency in regulatory standards and compliance.
* Assure that all aspects of the Company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.

Requirements:

Education
Bachelor's degree in scientific discipline required. Advance degree (M.S., PhD, Pharm D) is preferred. Oncology experience highly desired.

Experience
Minimum eight plus (8+) years direct Regulatory Affairs experience within the biopharmaceutical industry, including leading Health Authority meetings and submission of marketing applications in the US (required), EU or JP (desirable).

Technical Skills
* Demonstrated knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
* Strong written, verbal, and presentation skills, with the ability to effectively communicate regulatory data to cross functional teams and senior management.
* Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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