Senior Regulatory Affairs consultant plays a crucial role at one of our pharmaceutical clients as a key member of the Regulatory Affairs department, reporting to the Vice President of Regulatory Affairs. The successful candidate will be a key participant in the regulatory strategy and will be responsible for day to day activities including promotional materials review, managing change control, managing stability studies, assisting regulatory submissions, and collaboration with other departments to execute all assign responsibilities.



The company currently markets a diverse line of prescription human drugs, medical devices and dietary supplements focused in both the Women's Health and Dermatology fields. Our vision for growth is supported by a strong pipeline and dynamic team. The successful candidate should have a demonstrated command of US Drug Regulatory Affairs, with a firm understanding of documentation management, stability study, labeling and GMP for drug product, and Dietary Supplements. In addition, it is important to have excellent communications and presentations skills, and the ability to work collaboratively with external and internal partners.



Manage departmental file systems to ensure regulatory compliance, coordinate routine review of product labeling and promotional materials, and correspond with service providers to ensure effective communications.



Primary Duties and Responsibilities

• Maintain database of regulatory filing activities.

• Assist development of medical/technical e-file system.

• Coordinate review of labeling and promotional materials, and maintain files.

• Assist preparation of regulatory submissions, and maintain central files.

• Answer general inquiries using a professional and courteous manner

• Interface with internal and external functions to ensure accurate and efficient Regulatory Compliance and Product Quality Assurance activities.

• Prepare meeting agendas and supporting material for distribution/calendar management

• Assist in preparation of presentations to management team.

• Prepare labeling change control and manage review and approval process

• Managing stability study and reviewing data



Qualifications

• Bachelor Degree (Paralegal or Life Science preferred), with 2-3 years of experience.

• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Project)

• Proficiency in use of databases

Demonstrated organization skills and attention to detail required. Familiarity with FDA requirements is a plus.