Title: Director of Regulatory Affairs

Summary:

A development-stage bio-pharmaceutical company, dedicated to improving patient access to essential therapies and developing innovative treatments for serious diseases, is looking to bring on a Director of Regulatory Affairs to join their team! This company is growing rapidly and they are looking for someone to provide their expertise in generic drugs, ANDA submissions, and regulatory affairs CMC based out of their office in the greater Miami area. This role will give you a great opportunity to contribute to the company's mission to develop treatment options for diseases where therapeutic options are inadequate.

The Director will be responsible for…

• Formulating and executing regulatory strategies for the development of generic products, product modifications, and life-cycle management
• Actively engaging in the preparation, submission, and management of regulatory filings, with a primary focus on ANDA submissions for the FDA
• Contributing to and supervising the preparation of dossiers with external vendors, ensuring compliance with regulatory standards and guidelines
• Collaborating with cross-functional teams to compile and review submission materials
• Working closely with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are incorporated into product development and life-cycle processes

The Director should have the following qualifications:

• Bachelor's degree in a scientific discipline; advanced degree (MS, PhD) preferred
• 7 years of Regulatory Affairs experience in pharmaceutical industry
• Vast experience with regulatory submissions, especially ANDA submissions
• Strong interpersonal, leadership, and communication skills
• Thrives in fast-paced, hands-on environments
• Strong interpersonal skills, ability to work on a team, and communication skills