USASenior Associate Specialist, Regulatory Operations
3 нед. назад
USASeniorRemote
regulatory submissionsfda submissiontracker management
Senior Associate Specialist in Regulatory Operations responsible for regulatory submissions and operations supporting veterinary longevity drugs approval.
Обязанности
- We’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.
Требования
- 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
Условия
- 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
- Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.
Другое
- Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.
- We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future.
- Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.
- 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
- We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
- We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
- Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.
- Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
- We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
- Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.