Industry Sponsor: Ultragenyx
Program Details
The Ultragenyx Regulatory affairs team has 65 regulatory experts across multiple regulatory sub functions:
- Global Regulatory Strategy, Global Regulatory Operations, Global Labeling, Advertising and Promotion, Regulatory CMC, Regulatory Project Management, Regulatory Intelligence and Policy
During the fellowship, the fellow will work within Global Regulatory Strategy supporting a Global Regulatory Lead (GRL) on a Regulatory Sub-Team for one or more programs. They will be exposed to and gain experience across the various regulatory functions.
Expectations and Experience for the Fellow:
- Create clinical and regulatory strategies for developing advanced therapies (gene therapy, monoclonal antibodies and antisense oligonucleotides) to treat rare and pediatric diseases
- Serve as the regulatory point of contact between Ultragenyx and Health Authorities
- Lead the development, and submission of Investigational New Drugs (INDs) and Clinical Trial Applications (CTAs) to conduct clinical research for new therapies
- Work on planning and development New Drug Applications (NDAs), Biologics License Application (BLAs) for the US as well as Marketing Authorization Applications (MAAs) worldwide
- Collaborates with cross-functional teams to provide regulatory support to optimally design and implement successful drug development strategies
- Ensure teams' development plans are in compliance with global regulations and requirements
General Information:
- Position Title: Global Regulatory Affairs: Regulatory Strategy in Rare & Pediatric Diseases
- Length of Fellowship: 2 years
- Location: Bay Area, California (Novato or Brisbane)
Program Staff
Jonathon Parker, BSPharm, MSPharm, PhD
Vice President, Global Regulatory Strategy
Ultragenyx
Sandra Nino-Siddens, PharmD, MS
Vice President, Global Regulatory Strategy
Ultragenyx
Jad Adaimi, MS
Executive Director, Global Regulatory Strategy
Ultragenyx
Benefits
The fellow will receive a competitive stipend and benefits package, including comprehensive health and dental insurance. The fellowship will sponsor attendance at one or more professional meetings, conferences or workshops.
Eligibility
The fellow will be selected on a nationally competitive basis. To be eligible, candidates must be graduates of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program before the fellowship begins in July. Participation in the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Services (PPS) is strongly encouraged, but not required. The candidate must be eligible to work in the United States, as Purdue and Ultragenyx will not provide sponsorship to foreign students.
Application Process
Positions Available: 1
Location: Bay Area, California
All interested applicants must submit the following via email:
- Curriculum Vitae
- Letter of Intent
- Official college of pharmacy transcript (unofficial transcript can be submitted as placeholder)
- Two letters of recommendation (Please instruct your letter writers to directly send to email below)
Applications will open October 1st, 2023.
All application materials should be submitted electronically to the email contact below no later than 23:59 EST on Wednesday, November 15th, 2023.
Preliminary interviews will be conducted virtually on a rolling basis, beginning the week October 16th, 2023.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, Purdue University College of Pharmacy, in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 13th, 2023.