Senior Director, Regulatory Affairs (CMC) Brisbane, CA; or Novato, CA Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work.Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally andpersonally, come join our team . Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the SDIR will be responsible for developing, implementing, and advising on global CMC regulatory strategies for all development-stage programs and marketed products to secure and maintain market access for the products in line with business objectives , and in coordination with key internal and external stakeholders. This individual will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for development programs and commercial products in domestic and global markets, CMC regulatory strategic development plans and risk assessments, critical issues management and Health Authority interactions while ensuring that the most current requirements, standards, and trends within the company and industry are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with global regulatory agencies and business partners with regards to technical development, CMC regulatory, registration, and life-cycle management strategies. He/she will support/lead the development and implementation of department policies. The individual will maintain awareness of the global regulatory environment and assess and communicate the impact of changes on business, development programs, and commercial products. This position will report to the Vice-President of Regulatory Affairs CMC ultra innovative – Tackle rare and dynamic challenges Work Model: Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Provide strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for development programs and commercial products in domestic and global markets, CMC regulatory strategic development plans and risk assessments, critical issues management and Health Authority interactions Use extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise Articulate complex Regulatory CMC issues and support global development and commercialization of programs Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met Review CMC sections of IND/CTA, NDA/BLA/MAA, and other global submissions in support of clinical development, marketing applications, commercial product, and their amendments/supplements/variations in conformance with local regulatory requirements Liaise and negotiate with global regulatory authorities as needed for all aspects related to drug development including resolution of key CMC regulatory issues and to expedite approvals of product Maintain awareness of the global regulatory environment and assess the impact of changes on business, development programs, and commercial products Facilitate policy and development of the standard interpretation of global regulations Proactively manage critical CMC issues, taking leadership for the regulatory contribution Develop and implement department practices, policies, processes, and SOPs Requirements: BA/BS in a scientific field of study with 15 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry, including commercial experience in both small and large molecules and other modalities Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory/CMC teams, and developing and implementing complex CMC regulatory strategies for small molecule, biologics and/or combination products Strong business acumen and ability to make sound decisions that contribute positively to the business Excellent verbal and written skills; ability to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to the internal and external stakeholders in a timely manner Strong negotiation skills and ability to think creatively and develop creative solutions Ability to prioritize and handle multiple projects simultaneously Rare disease CMC regulatory experience is desirable LI-CS1 LI-Hybrid Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Long term incentive and Employee stock purchase plans or equivalent offerings · Fitness reimbursement Benefits vary by region and country Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com . It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters : All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to : talentacquisition@ultragenyx.com . Create a Job Alert Interested in building your career at Ultragenyx Pharmaceutical? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select Degree Select Select Candidate Preferred First Name Candidate Preferred Last Name Home Address City State LinkedIn Profile Are you willing to relocate? Select How did you hear about this job? Select Select Is it possible that you may require or request employment- based visa sponsorship to continue working in the United States, whether now or in the future? Select Are you related to anyone that is an employee, contractor or contingent worker for Ultragenyx (meaning person related by blood, adoption or marriage including stepchildren and stepparents)? Select Have you previously worked as an employee, contractor, contingent worker or in any other capacity for Ultragenyx? Select If you were referred, list the name of the person that referred you. Are you currently a contractor at Ultragenyx? 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Senior Director, Regulatory Affairs (CMC)