Swisher is seeking a Director, New Product Compliance to lead the planning and execution of regulatory compliance strategy for product development and commercialization. The role involves establishing and maintaining processes, systems, and governance to meet compliance requirements driven by governmental policies, regulations, standards, and guidelines.
Requirements
- Bachelor’s degree in a scientific, technical, or closely related field, or equivalent combination of education and directly relevant experience
- 8+ years of progressively responsible experience in regulatory compliance and product submissions within FDA regulated product categories
- Demonstrated ability to recognize and interpret regulatory changes, translate impact to the business, and define actions that inform and influence regulatory policy positions
- Proven ability to interface effectively with FDA and other regulatory agencies
- High level knowledge of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act
Benefits
- Base salary and bonus program
- Medical, dental, vision, life insurance
- Generous 401(k) Plan
- Defined Contribution Plan
- Paid vacation and paid holidays
- Tuition reimbursement