Senior Director, Regulatory Affairs (Clinical/Nonclinical Strategy)
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco, and Basel, Switzerland.
Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs (Clinical/Nonclinical Strategy), who is a team builder and enjoys a fast paced, dynamic work environment. The Senior Director will be responsible for developing, implementing and advising on global regulatory strategies for new and late stage programs to accelerate and ensure successful product registrations in line with business objectives. This individual will provide leadership, regulatory direction and mentorship on program strategy and execution including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority interactions, while ensuring that the latest requirements, standards and trends within the company and industry are met. This individual will have departmental and corporate level influence. Externally, the individual will interface with regulatory agencies and corporate partners in regards to development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. This position will report to the Vice President of Regulatory Affairs.
Responsibilities, including but not limited to:
- Provides strategic regulatory direction and mentorship on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority interactions.
- Ensure the successful implementation and execution of regulatory plans to support product approval and commercialization.
- Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development programs and marketed product regulatory issues to support corporate goals.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Able to synthesize complex scientific information and articulate regulatory issues
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages and ensures timelines are met.
- Reviews sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of products.
- Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates interpretation of global regulation.
- Proactively manages critical issues, taking leadership for the regulatory contribution.
- Develops and implements department policies, processes and SOPs.
- Minimum BA/BS degree in a scientific, medical, or related discipline. PhD (in a scientific discipline), PharmD or MD is preferred.
- A minimum of 12 years experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
- Extensive experience in submitting INDs, NDAs, and MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, and developing and implementing complex regulatory strategies
- Excellent written and verbal communication skills and presentation effectiveness
- Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products
- Well-developed critical reasoning skills and in risk management assessments
- Proven ability to collaborate across multiple functions and build effective relationships
- Excellent team interaction skills along with demonstrated ability to work in a cross functional team and influence the decisions of a team.
- Demonstrated excellence in independent management of complex projects
- Rare disease experience is desirable
- Business travel to be ~10-20% as required
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
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@example.com.