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 CMC - Japan will manage related chemistry, manufacturing and controls (CMC) regulatory activities/interactions and will help to develop regional regulatory CMC strategies for both established products and development products.
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:
- Develop the CMC regulatory strategies and manage related regulatory activities for assigned programs. Work with global and regional teams to prepare project plans and timelines for pipeline of products, including coordination and oversight of global regulatory CMC submissions.
- Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to Clinical Trial Notifications (CTN), NDAs, PCAs, MCNs, etc.
- Advise the global regulatory compliance of Ultragenyx pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation.
- Lead the preparation, review and filing of CMC sections of regulatory submissions and interactions with regional regulatory agencies.
- Oversee, coordinate and ensure the preparation of regulatory CMC submission documentation is prepared with quality and in a timely manner to meet regional regulatory requirements and corporate objectives.
- Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization.
- Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs Japan point of contact to global and cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, Manufacturing, contract organizations and consultants. Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.
- Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements.
Requirements:
- BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
- Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products
- Proven ability to analyze and organize information logically.
- In depth understanding and application of industry standards and international regulations and guidelines.
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally.
- The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.
- Strong collaboration, teamwork, organizational skills at attention to detail
- Excellent written and verbal English and Japanese communication skills.
#LI-CK1 #LI-Hyrid
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].
