This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the creation of regulatory strategies for designated projects or regions in development.

• Define the regulatory strategy for submission documents and communications with Health Authorities.

• Manage project timelines and plans to ensure proper prioritization of all initiatives and timely achievement of key objectives.

• Offer regulatory guidance to the GRA functional teams or projects that have moderate complexity or resource needs.

⛳️ Requirements

• A Bachelor's degree in Biology, Chemistry, or a related field.

• A decade of relevant experience in the pharmaceutical or biotech industries focusing on regulatory affairs, or an equivalent combination of education and experience.

• Required experience with market products, labeling, new drug development, and collaboration with the FDA.

• Advanced technical expertise in regulatory affairs science, including an understanding of regulatory frameworks and external environments.

• Thorough knowledge of research and development, as well as preclinical and clinical requirements related to drug registration and maintenance of human pharmaceuticals.

🏝️ Benefits

• Compensation, medical benefits, fringe benefits, and other employment terms and conditions will be provided by the third-party agency partner upon offer.

• Eligible for overtime pay in compliance with federal and state regulations.