Senior Associate Specialist, Regulatory Operations
$110,000–$160,000 year
Remote
Job Summary
Prepare and review clinical and CMC regulatory submissions, then package materials in the CVM eSubmitter tool for author review. Assemble, format, and publish submissions to FDA CVM and ex-US agencies, including INAD correspondence, technical sections, amendments, annual reports, and meeting requests. Manage transmissions through the FDA Electronic Submissions Gateway, handling account administration, receipt reconciliation, and troubleshooting failed transmissions. Maintain the submission archive and correspondence log to ensure rapid location of prior commitments, agency comments, or filed documents during reviews or inspections. Own regulatory document templates and the submission style guide while creating and maintaining submission trackers to keep the regulatory activity source of truth current. Collaborate with internal teams on product labeling and documentation while staying current on changes to FDA CVM and ex-US authorities.
Required Qualifications
- at least 3 years of regulatory ops experience
- Bachelor's degree in relevant field (biology, vet med, regulatory affairs or related)
- Knowledge of various regulatory submission types (H-submissions, Z-submissions, etc)
- Hands on experience with drafting, packaging and submitting regulatory submission and communications to the FDA via the ESG electronic submission system
- Collaborative with cross-functional teams who contribute to the various submissions (Research, Clinical, CMC)
- Ability to operate with a degree of autonomy and accountability when managing submissions
Desired Qualifications
- in Regulatory Ops eager to contribute to regulatory filings for Loyal's longevity pipeline
- comfortable collaborating with others within Regulatory, as well as regularly interfacing with members of other teams, such as Research, Clinical Development and CMC
- comfortable with various regulatory submission types for therapeutics (IND/INAD, NDA/NADA, Biologics, Meeting Requests, Supplements, etc.)
- 3-5 years of regulatory ops experience in human or animal health
- animal health preferred
- Familiarity with ex-US submission
- RAPS certification
- Excited about working at the forefront of regulatory category creation
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