Executive Director/Vice President, Regulatory Affairs - Novato, CA | Biospace
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Executive Director/Vice President, Regulatory Affairs

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
11/22/2016
Position Type:
Full time
Job Code:
2015-1301
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Director, Regulatory Affairs, Vice President, VP,

Job Description


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 headquarted in Novato, CA, 25 miles north of San Francisco and recently opened an office in Brisbane, CA.

Position Summary

Ultragenyx is seeking a highly motivated Exec. Director/VP, Regulatory Affairs for Development, who is a team builder and enjoys a fast paced, dynamic work environment.  The Exec. Director/VP will be responsible for providing global regulatory leadership in support of the global development, registration, and life-cycle management of Ultragenyx’ products, as well as oversight and mentoring for an established regulatory team under their area of responsibility.  He/she will provide leadership and direction to 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 Vice President of Regulatory Affairs.

Responsibilities
•   Provide global regulatory leadership in support of the global development, registration, and life-cycle management of Ultragenyx products
•   Oversee the development of short and long term global regulatory strategies in support of project objectives for Ultragenyx products
•   Oversee health agency meetings and strategic planning
•   Ensure the efficient, timely and compliant execution of regulatory strategies
•   Provide review and comments on Regulatory documents
•   Keep abreast of changes in the regulatory environment and implement necessary adaptations
•   Offer expert opinion, advice and strategic direction on emerging policy & intelligence matters (particularly in the rare disease, orphan drug and MS space).
•   Provide regulatory due diligence assessments of new business opportunities as required
•   Ensure continue professional development of staff
•   Provide senior staff advice and guidance on regulatory issues (e.g. helping with technical knowledge)
•   Determine timelines and budgets for department activities and report accordingly.

Requirements


•   BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
•   A minimum of 15 years in the biotechnology or pharmaceutical industry with a minimum of 2 years in a senior leadership role managing a large group.
•   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.

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.