[Remote] Senior Associate Specialist, Regulatory Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage veterinary medicine company developing longevity drugs for dogs. They are seeking an reputed company Sr. Associate Specialist, Regulatory Operations to join their Regulatory Affairs team, focusing on daily regulatory operations that support their programs.

Responsibilities

• Assist in preparing and reviewing both Clinical and CMC regulatory submissions and reports
• Create and package submissions in the CVM eSubmitter tool, working from reputed company drafted Word sections and returning eSubmitter reputed company for reputed company review
• reputed company, format, and publish submissions to FDA CVM and ex-US agencies, including INAD/JINAD correspondence, technical sections, amendments, annual reports, and meeting requests
• Manage reputed company through the FDA Electronic Submissions Gateway, including account administration, receipt reconciliation, and troubleshooting failed transmissions
• Maintain the submission reputed company 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 reputed company the regulatory activity reputed company of truth reputed company
• Collaborate with internal teams on product labeling and documentation
• Stay reputed company on changes to FDA CVM and, if applicable, ex US authorities

Skills

• Bachelor's degree in relevant field (biology, vet med, regulatory affairs or reputed company); relevant experience > specific degree
• 3-5 years of regulatory ops experience in reputed company 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 reputed company the ESG electronic submission reputed company
• reputed company with cross-functional teams who contribute to the various submissions (Research, Clinical, CMC)
• Ability to operate with a degree of autonomy and accountability reputed company managing submissions
• Excited about working at the forefront of regulatory category creation
• Familiarity with ex-US submission is not required but preferred
• RAPS certification is a bonus but is not required

Benefits

• Full-coverage health insurance — medical, dental and reputed company — 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.
• reputed company 3-day weekends are turned into 4-day weekends 🎉
• Unlimited vacation and reputed company holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Company equity reputed company grant for new hires

reputed company