What are the responsibilities and job description for the Clinical Dynamix, Inc. is hiring: Senior Director, Regulatory Affairs - Advertis position at Clinical Dynamix, Inc.?
Role Overview Responsible for all regulatory affairs activities required to support lead, manage, review, and submit regulatory submissions to FDA including supplements, and post-approval reporting activities of marketed products. Lead and manage regulatory activities for labeling, promotional and advertisements. Lead and manage state licenses regulatory compliance.
Primary Duties & Responsibilities
- Regulatory Affairs : o Lead and manage all regulatory affairs-related activities for products o Serve as the regulatory liaison for FDA submissions and communicationso Lead, manage, review, and submit documents eCTD submission to the FDA o Lead the management of all regulatory-related documents and maintain in complianceo Maintain all regulatory files information in compliance with regulatory authority requirementso Renew NDA and devices registrations and update listings with the FDAo Requests and legalizations of Certificates of Pharmaceutical Products and Price Certificates o Oversee the development of the US Compliance Program in collaboration with the Director of Complianceo Collaborate with external counsel to support marketing initiatives while ensuring compliance with FDA regulatory requirements
- Trade Labels and Promotional Labels : o Lead and manage all labeling preparation for all marketed Company products o Manage and coordinate all labeling artwork designing and proof preparation with artwork designer and implementing with CMO for the packaging.o Prepare labeling listing with FDAo Labeling-related change control to finalize labeling update documentso Develop, manage, review, and approve all promotional materials for all marketed productso Maintain traceability of all promotional material to comply with the regulatory requirementso Design labels to meet FDA requirements of the labeling and prepare labeling claim information for the product based on the performed study and FDA guidanceo Own PRC and create the process if needed, Also, will work with outside counsel on supporting marketing initiatives while maintaining compliance with the FDA regulatory requirements
- State License Management : o Lead and manage state licenses application for all Company USA, Inc., for all states
Additional Duties & Responsibilities
Requirements and Personal Skills