Vice President Regulatory Affairs
$285,000–$315,000 year
HybridSioux Falls, South Dakota, United States
Job Summary
Lead preparation, review, and submission of documents to the FDA and international health authorities to support biologics development across the product lifecycle. Manage and prioritize BLA, MAA, IND, and orphan drug applications while assessing quality, preclinical, and clinical documentation for regulatory submissions. Provide strategic guidance on regulatory risk assessments, scenario planning, and decision support to align regulatory objectives with corporate strategy and development timelines. Oversee labeling reviews, adverse event reporting, change controls, and inspection readiness through cross-functional collaboration with Clinical, Manufacturing, and Quality teams. Independently provide phase-appropriate strategic input for INDs and BLAs while managing regulatory policies, SOPs, and training programs. Participate in due diligence activities as required.
Required Qualifications
- Bachelors' degree in scientific field/healthcare/regulatory discipline
- 15+ years of RA roles with increasing responsibility within regulatory affairs at one or more biopharmaceutical/pharmaceutical companies
- Must have experience interacting with FDA, EMA, and MHRA
- Proven leadership experience in the establishment of INDs and approvals of BLAs
- Must have NDA, BLA, and MAA filing and approval experience
- Demonstrated knowledge of biologic manufacturing processes, GMP principles, and related FDA and ICH regulatory requirements
- Demonstrated experience in chemistry and manufacturing controls (CMC) and clinical issues and filings
- Management expertise and proven experience leading and developing high performance teams
- Ability to work effectively across teams, functions and with outside partners
- Familiar with US and International regulatory markets
- Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook)
- Ability to effectively present information in one-on-one, small groups and lab meetings
- Must regularly lift and/or move up to 10 pounds
- Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus
- Regular travel to SAB location and other sites/locations as needed
- Travel to the Sioux Falls facility projected at 1-2 weeks onsite per month initially followed by a regular cadence to the facility as needed
Desired Qualifications
- Advanced degree in relevant field
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs
- Excellent written and verbal communication skills
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.