The Associate Director, Regulatory Affairs is responsible for supporting regulatory activities, will write and prepare IND/NDA documents, contribute to the completion of projects, and ensure compliance with required FDA regulations.
•Write and prepare regulatory documents for submission to the FDA (specifically for INDs and NDAs).
•Review technical documentation.
•Maintain regulatory records, including archive of submissions and FDA correspondences files.
•Maintain up-to-date regulatory knowledge, including regulatory procedures and changes.
•Responsible for making sure submissions comply with applicable regulations and guidance documents.
•Track submissions and ensure timely filing of documents.
•Liaison with other internal departments regarding documentation and submissions.
•Manage project deliverables and timelines.
•Conduct or participate in meetings with internal teams and government agencies.
•Distribute agendas, take minutes and assign/follow up on action items.
•Ensures all assignments are completed within defined timelines and meet regulatory and other company guidelines.
•Other duties as assigned.
•4-year degree in Biological Sciences, Chemistry or Engineering required.
•Experience: 5-7+ years of direct, recent experience in Regulatory Affairs.
•Direct IND and NDA submission experience required.
•Intermediate understanding and utilization of regulations and guidances.
•Experience with pharmaceutical drugs is required; small molecules a plus.
•Ability to work independently.
•Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners.
•Must be flexible when priorities change and have the ability to complete tasks with a sense of urgency.
•Excellent written and verbal communication skills.
•Must be able to work successfully within a team.
Please submit your resume and cover letter to firstname.lastname@example.org. Please indicate the job title in the subject line of your email.