Manager, Regulatory Affairs
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
The Manager, Regulatory Affairs, is an individual contributor who will coordinate regulatory deliverables and interactions for select programs and will assist in developing regional regulatory strategies.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
Or
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:
- With appropriate guidance, this role will support contact with Health Authorities on select programs.
- Represent Regulatory in appropriate sub team meetings, serving as the point of contact for the assigned products, and interfacing with functional areas including Research, Development and Clinical in strategic development for early and late stage products.
- Provide regulatory guidance and input throughout product clinical development to
- Lead cross functional teams in Regulatory Filings (e.g. INDs, BLAs, CTAs, MAAs)
- Maintain INDs/CTAs ensuring Agency compliance
- Drive submissions on select programs
- Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance
- Lead teams in the development of briefing documents for Agency meetings
- Manage and direct contractors/vendors as needed on programs
- Keep current with Agency guidelines and regulations
- Prepare comments on draft documentation sent out for consultation from the health authority
- Contribute in creation of local labels as needed
- Coordinate submission schedule with Publishing, ensuring delivery of high quality documents
- Author and contribute to departing operating procedures and work instructions
Requirements:
- BA/BS in a scientific field of study or BA/BS in another field of study and 4-6 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry
- Strong knowledge and experience in interpretation of regulations and guidelines related to drug development
- In depth understanding and application of industry standards and international regulations and guidelines.
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally
- The desire and ability to work in a fast-paced, start-up environment
- Strong collaboration, team work, organizational skills at attention to detail
- Excellent written and verbal communication skills #LI-CS1 #LI-Hybrid
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$138,000 - $170,400 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
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