Senior Associate Specialist, Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Support the preparation and evaluation of Clinical and CMC regulatory submissions and reports.

• Generate and organize submissions using the CVM eSubmitter tool from sections drafted in Word and return the eSubmitter output for author evaluation.

• Compile, format, and submit documents to FDA CVM and international agencies, covering INAD/JINAD correspondence, technical sections, amendments, annual reports, and meeting requests.

• Oversee transmission through the FDA Electronic Submissions Gateway, including account management, receipt reconciliation, and resolving transmission issues.

• Maintain the submission archive and correspondence log, documenting prior commitments, agency feedback, and filed documents.

• Manage regulatory document templates and uphold the submission style guide.

• Develop and sustain submission trackers, ensuring the regulatory activity source of truth is up-to-date.

• Collaborate with internal teams on product labeling and documentation efforts.

• Stay informed on updates to FDA CVM regulations and, if relevant, international authorities.

• Report to the Head of Regulatory, CMC.

⛳️ Requirements

• Bachelor's degree in a relevant discipline (biology, veterinary medicine, regulatory affairs, or similar); relevant experience may substitute for specific degree.

• 3-5 years of experience in regulatory operations in human or animal health, with a preference for animal health.

• Understanding of various regulatory submission types (H-submissions, Z-submissions, etc.).

• Practical experience in drafting, packaging, and submitting regulatory documents and communications to the FDA via the ESG electronic submission system.

• Familiarity with international submissions is preferred but not mandatory.

• Ability to work collaboratively with cross-functional teams in Research, Clinical, and CMC.

• Capability to operate independently and with accountability when managing submissions.

• RAPS certification is advantageous but not essential.

• Enthusiasm for working at the cutting edge of regulatory category development.

🏝️ Benefits

• Comprehensive health insurance — medical, dental, and vision coverage — for you and your dependents.

• $1,000 stipend for home office equipment.

• $1,200 annual budget for learning opportunities such as books and courses.

• $250 monthly wellness budget for gym memberships, cleaning services, spa treatments, food, etc.

• All 3-day weekends are extended to 4-day weekends.

• Unlimited vacation and paid holidays.

• Paw-ternity leave — adopt a dog and enjoy a day off to bond with your new family member.

• Competitive salary.

• Equity options grant for new hires.