Executive Director, Regulatory Affairs (Clinical/Nonclinical Strategy)
Why Join Us?
To be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy 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.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
ultraimpact – Make a difference for those who need it most
Ultragenyx is seeking a highly motivated Exec. Director, Regulatory Affairs (Clinical/Nonclinical Strategy), who is a team builder and enjoys a fast paced, dynamic work environment. The Exec. Director will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of Ultragenyx’ products, as well as for the oversight and mentoring of an established regulatory team. He/she will provide leadership and direction for the global regulatory aspects of Ultragenyx products, including developing long and short-term planning of regulatory projects that align with the company’s business plan, and developing strategies to ensure effective achievement of regulatory/business objectives. This individual will have departmental and corporate level influence. Externally, the individual will interface with outside regulatory agencies, corporate partners and vendors in regards to development, regulatory, and registration strategies. He/she will 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 Senior Vice President of Regulatory Affairs.
Responsibilities, including but not limited to:
- Provides regulatory leadership in support of the development, registration, and life-cycle management of Ultragenyx products
- Guides, coaches and manages a team of regulatory professionals to ensure their professional development and advancement
- 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
- 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.
- Approves 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.
- 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.
- Provides regulatory due diligence assessments of new business opportunities as required
Technical Requirements & Skills:
- BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
- A minimum of 13 years in the biotechnology or pharmaceutical industry with at least 5 years of leadership experience managing a regulatory team.
- Extensive experience in Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, and developing and implementing complex regulatory strategies.
- Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
- Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business.
- Excellent operational skills including demonstrated ability in planning, organizing and ability to motivate and lead others.
- Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders, including Senior Management.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure an acting with integrity and credibility to build trust
- Ability to deal effectively with a variety of personnel across a matrix organization
- Strong sensitivity for a multicultural/multinational environment
- Ability to prioritize and handle multiple projects simultaneously.
- Sense of urgency and perseverance to achieve results
- Rare disease experience is desirable.
- Business travel to be ~10-20% as required.
- Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
- Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your team and across the organization.
- Provide Ongoing Coaching & Feedback: Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.
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: firstname.lastname@example.org.