Job Details

Are you a regulatory expert with a passion for animal health?

Pegasus Laboratories, Inc., a leading innovator in veterinary pharmaceuticals and medical products, is hiring a Regulatory Affairs Manager to join its team on-site in Pensacola, FL.

As the Regulatory Affairs Manager, you'll leverage your regulatory expertise to secure new animal drug approvals and maintain existing products. You will oversee NADA and ANADA submissions, evaluate materials for compliance, and manage pre- and post-approval projects to ensure regulatory adherence and minimize FDA enforcement risks.

Position Responsibilities:
•Partner with product development managers to prepare and submit pre-approval technical sections, manage project invoices and budgets, and support in-life study activities as needed
•Manage electronic submissions and associated technical documentation, ensuring post-approval regulatory requirements and commitments are met
•Assess product changes, including labels and manufacturing modifications, to determine submission requirements and ensure compliance
•Collaborate with marketing as a subject matter expert to provide guidance and conduct annual reviews of all approved and unproved product labels, promotional materials, and website content
•Oversee FDA Structured Product Labeling (SPL) database, maintaining accurate product listings and certifications

Position Requirements:
•Bachelor's or Master's degree with 8+ years' experience in pharmaceutical or FDA/CVM related industry; DVM or PhD with 5+ years' experience in pharmaceutical or FDA/CVM related industry
•Experience in animal health, new product development, and FDA/CVM regulatory affairs preferred
•Pharmaceutical experience in a cGMP environment and basic knowledge of GMP and FDA regulations is preferred
•Familiarity with eSubmitter, Microsoft Dynamics 365 or related ERP systems, and Master Control is preferred
•Proficient in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook)

Join our team and help shape the future of animal health by ensuring our products adhere to the highest regulatory standards-apply today!

PBI-Gordon Companies and its subsidiaries are proud to offer a comprehensive benefits package to eligible, full-time employees who work 30 hours per week or more. Full-time employees will become eligible to participate in benefits on the first of the month following their start date, unless stated otherwise below. (Note: Interns, temporary or part-time employees, do not qualify for eligibility.)

Medical Insurance
PBI-Gordon Companies and its subsidiaries 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
The 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)
PBI-Gordon Companies and its subsidiaries 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
The 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
PBI-Gordon Companies and its subsidiaries believes 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.

This organization is an Equal Employment Opportunity employer and a supporter of affirmative action with a strong commitment to diversity, equity, and inclusion. All qualified applicants are considered for employment without regard to membership in any protected class by federal, state, and/or local laws.