Manager, Regulatory Affairs

Industry:

Company: Kyowa Kirin North America

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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

Summary:

The Manager, Regulatory Affairs provides regulatory, strategic and tactical support for assigned investigational and post-marketing projects. This role represents 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.

Essential Functions:
• Serve as the Regional Regulatory Leader (RRL) or provide regional support for assigned products, ensuring regulatory strategies align with business objectives.
• Collaborate with Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
• Lead the development and creation of regional regulatory strategies for assigned clinical development projects and marketed products at all lifecycle stages (Phase 1 through post-marketing).
• Lead, author, and review regulatory documents for submission to U.S., Canadian, and/or other international regulatory agencies. This includes major applications (e.g., INDs/CTAs, NDAs/BLAs, NDSs, MAAs, orphan drug designations) and routine/maintenance submissions, as well as preparing for formal meetings with health authorities.
• Provide strategic guidance and leadership to the Filing Submission Team and contribute to other project sub-teams as required.
• Play a key role in preparing for meetings with health authorities, including leading FDA or Health Canada meetings under management oversight.
• Create, maintain and update Regional Regulatory Strategies and input into the Global Regulatory Strategic Documents.
• Proactively identify and escalate potential Regulatory issues to management and develop risk evaluations and mitigation strategies.
• Oversee regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations when necessary.
• Review regulatory requirements to support submissions or inquiries from functional groups
• Stay current on changes in regulatory landscape and serve as a resource to functional groups for regulatory information.
• Represent Regulatory Affairs at change control team meetings and contribute to reviews and approvals of change controls (excluding CMC topics).
• Oversee CCDS and labeling activities in accordance with company SOPs.

Requirements:

Education
Bachelors’ degree in life sciences. Advanced degree (M.S., PharmD or Ph.D.) a plus.

Experience
• Minimum three (3) years of Regulatory Affairs experience in biotech/pharmaceutical industry, or equivalent. Oncology experience is desired.
• Experience working at a Japanese based pharmaceutical company a plus.

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.

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 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. 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 usprivacyoffice@kyowakirin.com.
Recruitment & Staffing Agencies

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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