Manager, Regulatory Affairs

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

Provide regulatory, strategic and tactical support for assigned investigational and post-marketing projects; represent Regulatory Affairs on global project teams and management committees; ensure compliance with routine/ maintenance submissions; remain current on global regulatory requirements with attention to US and Canada; demonstrate excellent interpersonal skills and the ability to lead multiple tasks.

Essential Functions:

•    Regional Regulatory Leader (RRL) or regional support for 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.
•    Support/lead developing and creating regional regulatory strategies for assigned clinical development projects and marketed products at all lifecycle stages (Phase 1 through post-marketing).
•    Support/lead authoring of and / or review of regulatory documents for submission to US and Canada, and/or other Rest of World regulatory agencies in support of formal meetings with health authorities, major applications (INDs / CTAs, NDAs / BLAs, NDSs, MAAs, orphan, etc.), and manage preparation of routine/maintenance submissions. 
•    Provide leadership and strategic input to the Filing Submission Team and support other project sub-teams, as assigned.
•    Contribute significantly to the preparation of Health Authority meetings; may lead FDA or Health Canada meetings with management oversight. 
•    Create and maintain Regional Regulatory Strategies and input into the Global Regulatory Strategic Documents.
•    Proactively 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.
•    Represent regulatory at change control team meetings and contribute to reviews and approvals of change controls (outside of CMC topics)
•    Manage CCDS and labeling activities according to company SOPs

Requirements:

Education
•    Candidates must have completed a 4-year college degree, preferably a Bachelor of Science in the life sciences, or advanced degree (eg, M.S., PharmD or Ph.D.).

Experience
•    Minimum of 2-4 years of work experience in the pharmaceutical industry. 
•    Previous oncology experience is preferred.

Technical Skills
•    Standard computer proficiency

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

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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