About the roleWe're seeking an experienced Sr. Associate Specialist, Regulatory Operations to join the Regulatory Affairs team at Loyal who will be working directly on our day-to-day regulatory operations that support our programs. This is a role for someone who is familiar with the operational aspects of regulatory affairs, such as compiling and formatting regulatory submissions, electronically submitting materials to the FDA/CVM and is able to be accountable for creating, own and updating trackers regarding our submissions. Your work will directly shape the regulatory path to bring novel longevity therapeutics through FDA CVM approval for the first time in any species, setting regulatory precedent for an entirely new category of medications.
This role is for someone who has at least 3 years of regulatory ops experience. The ideal candidate should be in Regulatory Ops eager to contribute to regulatory filings for Loyal's longevity pipeline. This person should be comfortable collaborating with others within Regulatory, as well as regularly interfacing with members of other teams, such as Research, Clinical Development and CMC. You should be comfortable with various regulatory submission types for therapeutics (IND/INAD, NDA/NADA, Biologics, Meeting Requests, Supplements, etc.) and be able to autonomously execute on tasks once the strategy has been outlined by Regulatory Ops leaders.
You will be reporting to our Head of Regulatory, CMC.
Your daily work will include- Assist in preparing and reviewing both Clinical and CMC regulatory submissions and reports
- Create and package submissions in the CVM eSubmitter tool, working from author drafted Word sections and returning eSubmitter output for author review
- Assemble, format, and publish submissions to FDA CVM and ex-US agencies, including INAD/JINAD correspondence, technical sections, amendments, annual reports, and meeting requests
- Manage transmission through the FDA Electronic Submissions Gateway, including account administration, receipt reconciliation, and troubleshooting failed transmissions
- Maintain the submission archive and correspondence log so that any prior commitment, agency comment, or filed document can be located quickly during a review cycle or an inspection
- Own regulatory document templates and the submission style guide
- Create and maintain submission trackers, and keep the regulatory activity source of truth current
- Collaborate with internal teams on product labeling and documentation
- Stay current on changes to FDA CVM and, if applicable, ex US authorities
About you- Bachelor's degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree
- 3-5 years of regulatory ops experience in human or animal health; animal health preferred
- 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
- Familiarity with ex-US submission is not required but preferred
- 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
- RAPS certification is a bonus but is not required
- Excited about working at the forefront of regulatory category creation
Salary range: $110,000 - $160,000
Loyal benefits- Full-coverage health insurance - medical, dental and vision - for you and your dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget for books, courses, etc.
- $250/month wellness budget for gym, cleaners, spa, food, etc.
- All 3-day weekends are turned into 4-day weekends
- Unlimited vacation and paid holidays
- Paw-ternity leave - adopt a dog and get a day off with your new family member
- Competitive salary
- Company equity options grant for new hires
