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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:

1. 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.
2. 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.
3. 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.
4. Lead the preparation, review and filing of CMC sections of regulatory submissions and interactions with regional regulatory agencies.
5. 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.
6. 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.
7. 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.
8. Provide guidance and advice on regulatory CMC environments; provide assessment of the impact of new and changing regulations/requirements.

Requirements:

1. BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
2. Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products
3. Proven ability to analyze and organize information logically.
4. In depth understanding and application of industry standards and international regulations and guidelines.
5. Experience in communicating regulatory strategy, submission documents and plans both internally and externally.
6. The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.
7. Strong collaboration, teamwork, organizational skills at attention to detail
8. Excellent written and verbal English and Japanese communication skills.

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