Responsibilities
- Evaluate regulatory background, product classification, disease context, and applicable standards to inform and adjust regulatory submission strategies and assess approval implications.
- Review quality, nonclinical, and clinical data packages to ensure they meet regulatory expectations and internal objectives for study and marketing applications.
- Draft regulatory submissions and supporting documentation, including CTD modules, for filings such as CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations, and Letters to File.
- Verify that nonclinical, clinical, and quality data align with regulatory strategy and support intended product claims and compliance goals.
- Maintain constructive communication with regulatory authorities through written and verbal interactions on submission reviews, meeting planning, and pathway clarification.
- Provide expert guidance to internal teams on regulatory expectations for data required in clinical and marketing applications.
- Support assessment of the evolving regulatory landscape and contribute regulatory insights across the product lifecycle, from concept through commercialization.
- Lead regulatory project tasks with strong organizational, writing, and coordination skills, focusing on technical and scientific regulatory execution.
- Apply comprehensive expertise in global regulatory frameworks, legal requirements, guidelines, and submission procedures.
Benefits
- Eligible for performance-based bonus
- Comprehensive benefits package included
Work Arrangement
Remote
Work Flexibility
Remote
Travel Percentage
10%
Posting Date
1/16/2026
Equal Opportunity Employer
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
Compensation Disclosure Policy
Employees with access to compensation data may only disclose pay information when responding to a formal complaint or charge, in support of an investigation or legal proceeding, or as required by law.
