Kyowa Kirin North America - Principal I, Global Regulatory Affairs-CMC

• EducationBachelor’s degree  in a relevant scientific discipline, such as Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or closely related field. Advanced degree (M.S., Pharm.D., Ph.D., or equivalent) preferred, particularly in a pharmaceutical, scientific, or regulatory discipline. • Experience•    Minimum eight (8) years of progressive regulatory affairs experience within the biotechnology, pharmaceutical, or life sciences industry, with substantial focus on CMC regulatory affairs.•    Proven track record supporting U.S. BLA post-approval activities and lifecycle management; exposure to regulatory activities in other major markets (e.g., EU, UK, and ROW) preferred.•    Demonstrated success managing complex regulatory CMC activities and projects across multiple functions, including site, technical, quality, manufacturing, and global regulatory organizations.•    Prior involvement in FDA interactions and health authority engagements, including preparation of regulatory materials, responses to agency questions, and follow-up activities.•    Background in manufacturing site regulatory activities, including technology transfers, manufacturing changes, facility readiness, and evaluation of regulatory impact.•    Hands-on involvement in the preparation, submission, and/or maintenance of Type V DMFs or other CMC regulatory dossiers strongly preferred.•    Demonstrated application of regulatory strategy and sound judgment to identify risks, evaluate options, and develop practical approaches to complex CMC issues.•    Track record of working effectively within a matrixed organization and influencing outcomes across site-based and global functions without direct authority. • Technical Skills•    In-depth knowledge of U.S. FDA biopharmaceutical CMC regulatory requirements, including expectations for development, manufacturing, post-approval changes, technology transfer, and lifecycle management.•    Strong understanding of the FDA PreCheck Pilot Program and its regulatory framework, including the role of early FDA engagement, facility information, Type V DMFs, pre-operational reviews, facility readiness, and subsequent application and inspection activities.•    Proficiency in CMC regulatory submissions and documentation, including BLA-related CMC content, post-approval supplements, Type V DMFs, regulatory responses, and supporting technical documentation.•    Regulatory strategy and analytical capabilities to evaluate CMC regulatory risks, interpret complex technical information, and develop practical, risk-based recommendations.•    Advanced regulatory writing and presentation capabilities, with the ability to communicate complex scientific and regulatory concepts clearly to technical, site, senior leadership, and health authority audiences.•    Cross-functional communication and stakeholder management skills, with the ability to build alignment, influence decision-making, and effectively communicate regulatory strategy and risk across site and global functions.•    Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook; familiarity with electronic regulatory submission and document management systems preferred.•    Familiarity with electronic regulatory submission and document management systems and other tools used to prepare, track, and maintain regulatory documentation preferred.prepare, track, and maintain regulatory documentation preferred. • Non-Technical SkillsDemonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization. • Physical Demands: • Physical Demands: • Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC; normal office environment with prolonged sitting and extensive computer work.Work is 100% on-site.  This is not a hybrid or remote role. • Working Conditions: • Working Conditions: • Requires up to 10% domestic and international travel • The anticipated salary for this position will be $140,000 to $175,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. • $140,000 to $175,000. • The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: • 401K with company matching • Annual Bonus Program (Sales Bonus for Sales Jobs) • Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days • Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) • HSA & FSA Programs • Well-Being and Work/Life Programs • Long-Term Incentive Program (subject to job level and performance) • Life & Disability Insurance • Concierge Service • Tuition Assistance • Employee Referral Awards • The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. • 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 [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]. • 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. • #LI-TT1 #Sanford #OnSite