What are the responsibilities and job description for the Regulatory Affairs Manager position at Pegasus Laboratories, Inc.?
At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!
SUMMARY:
The Regulatory Affairs Manager utilizes compliance expertise to achieve new animal product approvals (drug, device and nutritional) and maintain currently approved products on the market. This position compiles, reviews and submits materials for (A)NADA and (J)INAD regulatory submissions, providing technical and tactical regulatory operations required to manage pre- and post-approval projects and submissions to ensure regulatory compliance and reduce risk of FDA enforcement action.
RESPONSIBILITIES:
Medical Insurance
We are committed to helping you and your dependents maintain health and wellness by offering voluntary, competitive medical insurance and prescription drug plan options.
Dental Insurance
Choose from two voluntary dental plans that are designed to help protect you and your dependents' oral health.
Vision Insurance
Our voluntary vision insurance plan is designed to help protect you and your dependents eye health. Coverage is available for eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan.
Life Insurance with Accidental Death & Dismemberment (AD&D)
We offer a company-paid $50,000 life insurance policy with AD&D. You also have the opportunity to purchase additional life and AD&D insurance for yourself, your spouse and/or your dependent children. The cost for this coverage is based on the amount you elect and your age.
Short- and Long-term Disability
Our company-paid short-term and long-term disability plans to provide income replacement in the event you are not able to work due to illness or injury. Short-term disability will provide 70% income replacement up to $1,350 per week and long-term disability will provide 60% income replacement up to $5,000 per month.
Employee Assistance Program (EAP)
EAP Services are company paid to benefit all employee-owners and their families. EAP provides up to six free counseling sessions to help you and your family members manage life stressors, solve personal or relationship concerns, and achieve your goals.
Flexible Spending Account (FSA)
Flexible Spending Plans offer employee-owners the option to set aside pre-tax monies into a medical reimbursement or dependent care account to help pay for out-of-pocket medical, dental or vision expenses or day care costs. The maximum contributions are determined by the IRS and adjusted annually. This is a use-it-or-lose-it account, meaning any funds remaining in the account following the close of the plan year will be forfeited.
Pet Insurance
We love our pets! Pet insurance options for your furry friends is offered through the ASPCA. Employee-owners can enroll and pay premiums directly to ASPCA.
Paid Holidays & Paid Time Off (PTO)
Everyone needs time off to rest and recharge! Paid time off includes Regular PTO, Personal PTO, and specified paid company holidays. *The amount of paid time off (PTO) depends upon the employee's position and years of service.
Employee Stock Ownership Plan (ESOP)
We act like we own the company because we do! An ESOP provides employees with an ownership stake in the company. It's an additional form of compensation directly tied to PBI-Gordon Companies financial success. All regular employees are eligible to participate in the ESOP the first of the month following 30 days of service. PBI-Gordon Companies contributes approximately 18% of total compensation annually with a six-year vesting schedule. Our ESOP is more than a benefit, it is a key part of a culture, and it can provide significant rewards in retirement!
401(k) Retirement Savings Plan
Saving for retirement is one of the most important financial decisions you can make. We offer a 401(k)-retirement savings plan to assist employees with this important financial goal. New employee owners are eligible to participate the first of the month following 30 days of employment. We provide a company match of 100% up to 3% deferral with a three-year vesting schedule.
Fitness Reimbursement
We believe regular exercise helps improve overall health and job performance. PBI-Gordon will reimburse up to a maximum of $300 annually for gym/fitness memberships.
William Everett & Mary Ellen Mealman Scholarship Fund
Children or grandchildren of employee-owners may apply for a scholarship under the William Everett & Mary Ellen Mealman scholarship fund. Applicants are awarded based on financial need, academic achievement, and involvement in extracurricular/community activities.
Tuition Reimbursement
After one full year of employment, employee-owners are eligible for tuition reimbursement for bachelor's level coursework related to their current job or any future job offered at PBI-Gordon Companies.
Parental Leave
Company paid parental leave is offered to employee-owners following the birth of a child or the placement of a child with an employee in connection with adoption, foster care, or surrogacy. This policy will run concurrently with Family and Medical Leave Act (FMLA) leave, as applicable.
If you are a California resident, you have rights under the California Consumer Privacy Act (CCPA).
Please see our CCPA disclosure for more information.
Employment is contingent upon and may not begin until the successful completion of a pre-employment background and drug screen.
SUMMARY:
The Regulatory Affairs Manager utilizes compliance expertise to achieve new animal product approvals (drug, device and nutritional) and maintain currently approved products on the market. This position compiles, reviews and submits materials for (A)NADA and (J)INAD regulatory submissions, providing technical and tactical regulatory operations required to manage pre- and post-approval projects and submissions to ensure regulatory compliance and reduce risk of FDA enforcement action.
RESPONSIBILITIES:
- Prepare and submit electronic submissions to the FDA Center for Veterinary Medicine (CVM), review associated technical documentation and ensure all post-approval regulatory requirements and commitments are met (MCSR, DER, 2301). Engage with CVM on submissions when necessary, and track through full submission process to approval.
- Partner with marketing as subject matter expert to provide guidance and perform review of all approved and unapproved product labels, promotional materials, and website content.
- Manage the FDA Structured Product Labeling (SPL) database: create new listings, submit updates, perform annual review and certification. Monitor and implement State-related regulatory and labeling updates to ensure ongoing compliance across all jurisdictions.
- Ensure compliance with DEA regulations, including registration maintenance (year-end report, quota request, import/export permit), monitoring and reporting of controlled substance inventory, inspection readiness, and coordination of required documentation for procurement and usage.
- Work cross-functionally across Quality, Marketing, Sales, and Operations as a subject matter expert on regulatory requirements on department-specific deliverables. Shapes submission decisions, anticipates regulatory challenges, and reduces risk.
- Evaluate pre- and post-approval change controls, labels, and manufacturing changes to determine impact and submission requirements to align with regulatory strategies.
- Work with product development managers to prepare and submit major and minor pre-approval technical sections, process project-related invoices, track project budgets, and assist with nonclinical and clinical regulatory activities as needed.
- All tasks as requested or assigned.
- Bachelor's Degree in Life Science or related field MS, PhD. in Life Science or related field preferred.
- B.S. or M.S. with 8 years' experience in pharmaceutical or FDA/CVM related industry; PhD with 5 years' experience in pharmaceutical or FDA/CVM related industry.
- Experience in animal health, compliance, and/or regulatory affairs required.
- Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) required.
- Experience with eSubmitter software, Master Control (or related QMS) and Microsoft Dynamics 365 (or related ERP) preferred.
- Travel up to 10%
Medical Insurance
We are committed to helping you and your dependents maintain health and wellness by offering voluntary, competitive medical insurance and prescription drug plan options.
Dental Insurance
Choose from two voluntary dental plans that are designed to help protect you and your dependents' oral health.
Vision Insurance
Our voluntary vision insurance plan is designed to help protect you and your dependents eye health. Coverage is available for eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan.
Life Insurance with Accidental Death & Dismemberment (AD&D)
We offer a company-paid $50,000 life insurance policy with AD&D. You also have the opportunity to purchase additional life and AD&D insurance for yourself, your spouse and/or your dependent children. The cost for this coverage is based on the amount you elect and your age.
Short- and Long-term Disability
Our company-paid short-term and long-term disability plans to provide income replacement in the event you are not able to work due to illness or injury. Short-term disability will provide 70% income replacement up to $1,350 per week and long-term disability will provide 60% income replacement up to $5,000 per month.
Employee Assistance Program (EAP)
EAP Services are company paid to benefit all employee-owners and their families. EAP provides up to six free counseling sessions to help you and your family members manage life stressors, solve personal or relationship concerns, and achieve your goals.
Flexible Spending Account (FSA)
Flexible Spending Plans offer employee-owners the option to set aside pre-tax monies into a medical reimbursement or dependent care account to help pay for out-of-pocket medical, dental or vision expenses or day care costs. The maximum contributions are determined by the IRS and adjusted annually. This is a use-it-or-lose-it account, meaning any funds remaining in the account following the close of the plan year will be forfeited.
Pet Insurance
We love our pets! Pet insurance options for your furry friends is offered through the ASPCA. Employee-owners can enroll and pay premiums directly to ASPCA.
Paid Holidays & Paid Time Off (PTO)
Everyone needs time off to rest and recharge! Paid time off includes Regular PTO, Personal PTO, and specified paid company holidays. *The amount of paid time off (PTO) depends upon the employee's position and years of service.
Employee Stock Ownership Plan (ESOP)
We act like we own the company because we do! An ESOP provides employees with an ownership stake in the company. It's an additional form of compensation directly tied to PBI-Gordon Companies financial success. All regular employees are eligible to participate in the ESOP the first of the month following 30 days of service. PBI-Gordon Companies contributes approximately 18% of total compensation annually with a six-year vesting schedule. Our ESOP is more than a benefit, it is a key part of a culture, and it can provide significant rewards in retirement!
401(k) Retirement Savings Plan
Saving for retirement is one of the most important financial decisions you can make. We offer a 401(k)-retirement savings plan to assist employees with this important financial goal. New employee owners are eligible to participate the first of the month following 30 days of employment. We provide a company match of 100% up to 3% deferral with a three-year vesting schedule.
Fitness Reimbursement
We believe regular exercise helps improve overall health and job performance. PBI-Gordon will reimburse up to a maximum of $300 annually for gym/fitness memberships.
William Everett & Mary Ellen Mealman Scholarship Fund
Children or grandchildren of employee-owners may apply for a scholarship under the William Everett & Mary Ellen Mealman scholarship fund. Applicants are awarded based on financial need, academic achievement, and involvement in extracurricular/community activities.
Tuition Reimbursement
After one full year of employment, employee-owners are eligible for tuition reimbursement for bachelor's level coursework related to their current job or any future job offered at PBI-Gordon Companies.
Parental Leave
Company paid parental leave is offered to employee-owners following the birth of a child or the placement of a child with an employee in connection with adoption, foster care, or surrogacy. This policy will run concurrently with Family and Medical Leave Act (FMLA) leave, as applicable.
If you are a California resident, you have rights under the California Consumer Privacy Act (CCPA).
Please see our CCPA disclosure for more information.
Employment is contingent upon and may not begin until the successful completion of a pre-employment background and drug screen.
Salary : $300
