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 and personally, come join our team.
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
The Director of Regulatory Affairs Japan is responsible for providing strategic and operational support for the planning, management and execution of regulatory activities for Ultragenyx development products within Japan. This role is also responsible for ensuring that the country regulatory strategies are executed in compliance with applicable Japanese regulations and standards.
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:
- In alignment with Ultragenyx’s global regulatory strategies, assists in the development and implementation of country regulatory strategies for Ultragenyx development and marketed products.
- Serves as a liaison to country regulatory Health Authorities including Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health, Labour and Welfare (MHLW) and other regional authorities and provides guidance and advice on regulatory and policy developments within the region to Ultragenyx’s global regulatory team and other key stakeholders; actively maintains knowledge of regional regulatory requirements (e.g. new regulations, laws, etc.).
- Manages customization of dossiers for Japan and organizes submission and registration of Ultragenyx’s products in a professional, compliant, and timely manner.
- Supports strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions, including, but not limited to PMDA consultations and Marketing Authorization Approvals (MAAs), and created and/or customized regulatory dossiers for the registration of Ultragenyx’s products.
- Develops and/or maintain regulatory strategy and plan for Clinical Trial Notifications (CTNs) submissions for investigational drugs/products, ensure compliance with applicable regulatory requirements for CTNs.
- Supervises the regional Regulatory Affairs Teams/contractors for translation, submission of regulatory documents and contact with PMDA, MHLW and other regional Health Authorities.
- Collaborates with global/regional project teams and other internal and external key stakeholders as appropriate to ensure effective regional product registrations.
- Supports the co-ordination of contracted activities for translation, submission of regulatory documentation and contact with PMDA, MHLW and other regional Health Authorities.
- Performs other tasks and assignments as needed and specified by management.
Requirements:
- Expert with a minimum of 12 years progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO).
- Comprehensive understanding and ability to make appropriate judgements regarding pharmaceutical laws and regulations, product characteristics, business processes, manufacturing methods and manufacturing control, quality control operations and safety assurance operations.
- Prior experience helping to build a regional Regulatory Affairs function for a growing, international organization preferred. Rare disease and Regenerative medicinal Product experience are strongly preferred.
- In-depth knowledge of, and hands-on experience with, Japanese regulatory guidelines and requirements. Demonstrated, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions.
- Demonstrated track record of success building relationships with, and influencing, country, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
- Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities.
- Excellent verbal and written communication and skills, able to analyze, define and effectively convey difficult and complex subjects in a way that accurately and persuasively communicates the issues to the internal and external stakeholders
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Proficiency with Microsoft Office.
- Excellent written and verbal English.
#LI-CK1 #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
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
* 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 [email protected].
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
: [email protected].
