US Regulatory Strategy Lead
$185,000–$210,000 year
RemoteUnited States
Job Summary
Lead US regulatory strategy for assigned development and marketed products, partnering with the Global Regulatory Team to weave US approaches into global plans. Serve as the primary FDA contact for product(s), managing major agency meetings, triaging information requests, and facilitating submissions for IND, NDA, and BLA applications. Drive expedited regulatory pathways like ODD and Accelerated Approval while overseeing cross-functional teams, regulatory consultants, and due diligence assessments. Ensure timely, high-quality submissions and collaborate with commercial and labeling groups on product updates. Monitor evolving US regulations and guidance to support accelerated patient access.
Required Qualifications
- BS in a scientific discipline
- 6+ years regulatory affairs experience having led health authority meetings (FDA)
- Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
- Proven track record practicing sound judgment as it relates to risk assessment
- Highly conversant and knowledgeable of new and emerging regulations and guidance
- Understanding of GMPs, GLPs and GCPs
- Fluent written and verbal communication, presentation, and facilitation skills in English
- High ethical standards and ability to demonstrate Sobi values
- Strong negotiation skills and significant experience in interacting with regulatory authorities
- Risk identification and problem-solving skills
- Ability to manage complex issues and coordinate multiple projects simultaneously
Desired Qualifications
- Advanced degree (PhD, PharmD, MD) preferred but not required
- Experience with immunology late-stage development/marketed products ideal but not required
- Other therapeutic areas will be considered
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