You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

The Regulatory Coordinator is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry. This position involves administering and maintaining the company's annual product review and documentation change control system. The Regulatory Coordinator will also monitor regulatory activities and assist in maintaining master file documentation and databases.

Key Responsibilities

• Administer and maintain the Company’s Annual Product Review, including generating reports.
• Support administering and maintaining the Company’s Documentation Change Control System.
• Monitor regulatory activities through government internet websites and other communication channels.
• Assist in maintaining master file documentation and databases.
• Administer adherence to procedural requirements in developing Master Records.
• Support the development and implementation of regulatory strategies and submission standards.
• Interface with international third-parties to ensure regulatory compliance.
• Support R&D staff in compiling and submitting records for new product launches.
• Develop compliant Drug Facts Box information using FDA regulations.
• Maintain facility licenses and drug listings.

Education

• A 4-year technical college degree in a specialized field such as science or technology, or equivalent in knowledge and training.

Experience

• 2 to 3 years of experience in a pharmaceutical, regulatory environment.

Skills

• Attention to detail and ability to work well under pressure.
• Effective interpersonal skills for interacting with various levels of internal and external customers.
• Proficient in business English with good oral and written communication skills.
• Computer literacy in a Windows environment (Word, Excel, Outlook).
• Ability to prepare detailed and accurate documentation.
• Familiarity with FDA regulations, monograph system, and cGMP.
• Strong organizational and analytical abilities.
• Ability to work independently and manage multiple tasks.
• Discretion with confidential information and strong team player abilities.

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.