Why Join Us
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products. Come join our team during this exciting time of growth. We are located in Novato, CA, 28 miles north of San Francisco.
The Director, Regulatory Affairs will report to the Vice President, Regulatory Affairs. The Director will be responsible for global regulatory leadership, management and strategic guidance for all regulatory aspects (nonclinical, clinical, CMC) of one to two development stage programs. The responsibilities of this position include defining, implementing and delivering the global regulatory strategy for assigned programs. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development and be able to provide guidance in interpreting these rules, regulations, and guidelines. Strong leadership, communication (written and verbal), and management skills are required. A hands-on, can-do attitude is a must. The position level is dependent on experience and qualifications.
• Develop and implement global strategies to maximize the likelihood of regulatory success. Effectively communicate objective assessments of the likelihood of success of these regulatory strategies.
• Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory constraints.
• Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.• Lead regulatory activities to assure timelines and milestones are met to support the business needs of the company.
• Define content for and submit regulatory information to global regulatory agencies including, but not limited to, INDs, CTAs, BLAs, NDAs, MAAs. Develop and/or review regulatory and other applicable documents to ensure that all submissions are of high quality.
• Strategically plan, coordinate, prepare for, lead and execute meetings and teleconferences with regulatory agencies.
• Serve as primary contact for global regulatory authorities, corporate partners and consultants.
• Maintain knowledge of and monitor changes in current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s). Interpret relevent information and take appropriate action to inform and educate stakeholders and revise processes as necessary.• Staff, train and supervise a group of regulatory professionals
• Minimum BA/BS degree in a scientific, medical, legal or related discipline with at least ten years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries. PhD (in a scientific discipline), PharmD or MD is preferred.
• Thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development.
• Proven ability to successfully manage the preparation of regulatory submissions in the US, EU and ROW to deadlines
• Proven ability to successfully interact with and influence regulatory authorities.
• Demonstrated success in independent judgment in the performance of assigned duties.
• Demonstrated skills in complex reasoning and risk management assessments.
• Proven ability to lead multi-function organizations to achieve company objectives.
• Proven experience influencing without direct hierarchical authority, and affect change across organizational boundaries.
• Demonstrated success in creating a vision to inspire and lead a team to success.
• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
• Analytical, strategic thinker with proven leadership ability that demonstrates professionalism and establishes respect with excellent people management skills.
• Mentors and coaches others in technical and leadership areas.
• Ability to manage staff to achieve organizational objectives.
• Has past success in developing individuals and functional effectiveness.• Ability to handle simultaneous tasks and prioritize accordingly.