Job Description

Job Title:  Regulatory Affairs Specialist

Pay:  $35.00 - $38.00/hour
Benefits: Eligible to Enroll in Medical Benefits

Job Overview:  

• Manage product data on both internal Regulatory Affairs and external FDA data tracking/collection databases to ensure the company’s products, processes and physical sites continue to operate in a legal and ethical manner.
• Maintain current knowledge of federal and international regulations/standards/guidance documents, and internal policies and procedures to ensure compliance within Regulatory Affairs.
• Prepare, verify, and/or maintain technical files pertaining to submissions or other FDA-required activities throughout the product lifecycle. Understand and support the regulatory implications of the product profile

Requirements:

• BS Degree in Science.
• Minimum of 1 - 3 years of experience in Regulatory Affairs.
• Experience in Quality Assurance will be considered in lieu of Regulatory Affairs experience.
• Strong problem solving and critical thinking skills.
• Excellent written, verbal, and non-verbal communication skills.
• Excellent attention to the details.
• Solid organizational skills with capability to support multiple simultaneous projects.
• Strong technical (system) and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.).
• Strong knowledge of applicable regulations, standards and guidelines.
• Pinpoint Pharma is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.