Director, Global Labeling, Regulatory Affairs
Why Join Us
Ultragenyx is a 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.
We are headquartered in Novato, CA, 25 miles north of San Francisco with additional office space in Brisbane, CA.
Ultragenyx is seeking an experienced and highly motivated Regulatory Affairs Associate Director/Director, Global Labeling, who is a strong team player and enjoys a fast paced, dynamic work environment. In this position, the individual will be responsible for developing and executing the overall labeling strategy for products in development through commercialization. S/he will manage the development, review and approval of all labeling components including draft labeling text to support marketing applications, final package inserts, labels and company core data sheets (CCDS). The individual will also develop and oversee SOPs for the creation and management of global labeling activities. S/he may also review advertising, promotional and other related materials for assigned products to ensure compliance with applicable laws, regulations, and guidance. The individual must possess a thorough knowledge of global regulations for labeling and strong communication and project management skills. The position level is dependent on experience.
Responsibilities, including but not limited to:
- Develop and author draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to support marketing applications and labeling updates of approved package inserts to support product lifecycle management.
- Ensure labeling strategy is aligned with overall regulatory and program strategy by working closely with the regulatory strategy lead and development and project teams.
- Ensure labeling is complaint with US and EU regulatory requirements.
- Develop and maintain CCDS.
- Manage the review, QC and approval processes for all product labeling components and CCDS.
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities.
- Drive the development, implementation and maintenance of policies and procedures for the creation and management of labeling.
- Assist with the development of regulatory timelines related to labeling components and track deliverables to ensure regulatory submission timelines are met.
- Interface with functional areas (CMC, Nonclinical, Clinical, Safety, Technical Operations, and Commercial) to identify and obtain information required for development of labeling.
- May manage regulatory aspects of the review and approval process for product promotional materials and submission of US promotional materials to OPDP in a timely fashion.
- BA/BS Degree required, preferably in a health/life sciences or related field.
- A minimum of 10 years experience in the biotechnology or pharmaceutical industry including at least 6 years in a global labeling position.
- Thorough understanding of US CFR regulations, FDA guidance documents and EU requirements with respect to labeling.
- Ability to manage all aspects of labeling including package inserts, packaging labels and artwork development.
- Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
- Strong project management skills and ability to prioritize and handle multiple projects simultaneously.
- Rare disease experience is desirable.
- Business travel to be ~10% or 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: firstname.lastname@example.org.