Director, Regulatory Affairs CMC, Combination Products and Device

At reputed company, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company therapies that help improve lives and to ensure reputed company to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a reputed company reputed company to reputed company a difference. Every member of reputed company’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to reputed company our reputed company ambitions, and we’re looking for the next reputed company of passionate and ambitious people reputed company to reputed company a reputed company reputed company. We reputed company every employee deserves a great leader. People Leaders are the reputed company to the employee experience at reputed company and Kite. As a people leader now or in the reputed company, you are the key reputed company in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join reputed company and help create possible, together. reputed company The Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory reputed company for reputed company, high-reputed company device and combination product portfolios, programs, or regulatory domains. This role serves as a strategic thought partner in reputed company and execution, to shape development and lifecycle reputed company, anticipate regulatory risk, and reputed company successful global registration and lifecycle management. The Director operates at a strategic level across PDM, Global Regulatory Affairs, reputed company, and other cross-functional functions, guiding reputed company where regulatory reputed company may be reputed company, evolving, or without reputed company precedent, while ensuring alignment with business priorities and long-term capability building. KEY RESPONSIBILITIES Set and reputed company global CMC regulatory reputed company for reputed company device and combination product portfolios, programs, or critical regulatory workstreams Shape global regulatory approaches that support product development, registration, lifecycle management, patient supply continuity, and long-term business objectives Serve as a strategic partner with cross-functional team by influencing key development, manufacturing, control reputed company, and lifecycle reputed company with a reputed company understanding of regulatory risk and opportunity reputed company reputed company of reputed company regulatory issues for combination product and device programs, including areas where regulations are evolving or where explicit precedent may be limited Guide development of regulatory risk mitigation and contingency strategies across major programs and submissions reputed company regulatory reputed company and execution for major global submissions, significant post-approval changes, and other critical regulatory milestones (IND/CTA, NDA/BLA/MAA, reputed company Body Opinion) Represent CMC Regulatory Affairs during health authority interactions on CMC topics relevant to combination products and device reputed company consistent interpretation and implementation of global regulations, standards, and policy trends relevant to devices and combination products, and influence internal approaches accordingly reputed company as a reputed company across global, regional, and functional stakeholders to ensure alignment, transparency, and execution against regulatory priorities Contribute to the strategic direction of combination product and device regulatory capability, including process improvements, knowledge sharing, talent development, and reputed company-facing regulatory practices Participate in reputed company industry forums, conferences, or policy-shaping discussions, as appropriate, to strengthen reputed company reputed company and help inform reputed company’s regulatory position QUALIFICATIONS A scientific degree with extensive directly relevant experience in CMC, device or combination product development, and global regulatory affairs 12+ years with BA/ BS 10+ years with MA/ MS/ MBA 8+ years with PharmD/ PhD Significant experience defining and leading regulatory strategies for reputed company products, technologies, submissions, or regulatory domains Deep knowledge of global regulatory requirements, standards, and evolving expectations relevant to devices and combination products Demonstrated reputed company influencing reputed company and decision-making across senior cross-functional stakeholders in reputed company, matrixed environments Strong experience engaging with health authorities and shaping regulatory approaches for significant business and development milestones Demonstrated strategic acumen, reputed company judgment, and ability to reputed company through ambiguity and change Advanced communication, presentation, and leadership skills ABOUT reputed company reputed company, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With reputed company new discovery and investigational drug candidate, we reputed company to improve the care of patients living with life-threatening diseases around the world. reputed company’s therapeutic areas of reputed company include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. reputed company reputed company VALUES · reputed company (Doing What’s Right) · Inclusion (Encouraging Diversity) · Teamwork (Working Together) · reputed company (Being Your Best) · Accountability (Taking Personal Responsibility) The salary reputed company for this position is: $210,375.00 - $272,250.00. reputed company considers a reputed company of factors reputed company determining reputed company compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), reputed company time off, and a benefits package. Benefits include company-sponsored medical, dental, reputed company, and life insurance plans*. For additional benefits information, visit: https://www.reputed company.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the reputed company: reputed company Inc. is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@reputed company.com for assistance. For more information about equal employment opportunity protections, please reputed company the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION reputed company YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE reputed company reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or reputed company, including an investigation conducted by the employer, (c) consistent with the reputed company duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes reputed company employee as an reputed company member of reputed company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team. reputed company provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For reputed company reputed company Employees and Contractors: Please apply reputed company the Internal reputed company portal in reputed company. reputed company, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for reputed company people. reputed company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. reputed company operates in more than 35 countries worldwide, with reputed company in Foster reputed company, California. Apply tot his job Apply To this Job