What are the responsibilities and job description for the Senior Director, Regulatory Affairs - Advertising & Promotion position at Clinical Dynamix, Inc.?
Role OverviewResponsible for all regulatory affairs activities required to support lead, manage, review, andsubmit regulatory submissions to FDA including supplements, and post-approval reportingactivities of marketed products. Lead and manage regulatory activities for labeling, promotionaland advertisements. Lead and manage state licenses regulatory compliance.
Primary Duties & Responsibilities Regulatory Affairs : o Lead and manage all regulatory affairs-related activities for productso Serve as the regulatory liaison for FDA submissions and communicationso Lead, manage, review, and submit documents eCTD submission to the FDAo Lead the management of all regulatory-related documents and maintain incomplianceo Maintain all regulatory files information in compliance with regulatory authorityrequirementso Renew NDA and devices registrations and update listings with the FDAo Requests and legalizations of Certificates of Pharmaceutical Products and PriceCertificateso Oversee the development of the US Compliance Program in collaboration withthe Director of Complianceo Collaborate with external counsel to support marketing initiatives while ensuringcompliance with FDA regulatory requirements
Trade Labels and Promotional Labels : o Lead and manage all labeling preparation for all marketed Company productso Manage and coordinate all labeling artwork designing and proof preparation withartwork 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 allmarketed productso Maintain traceability of all promotional material to comply with the regulatoryrequirements
o Design labels to meet FDA requirements of the labeling and prepare labelingclaim information for the product based on the performed study and FDAguidanceo Own PRC and create the process if needed, Also, will work with outside counselon supporting marketing initiatives while maintaining compliance with the FDAregulatory requirements
State License Management : o Lead and manage state licenses application for all Company USA, Inc., for all states
Additional Duties & Responsibilities
Business Development : o Provide regulatory due diligence evaluation of products under consideration foracquisition
Audits & Inspections : o Support the auditso Host regulatory authority inspections by NJ Department of Health and US FDACompetencies / Career levelDemonstrated ability to multitask across technical, regulatory,and quality assurance functions. Expertise in regulatory operations, including CMClabeling, promotional materials, FDA regulations for NDAs, medical devices, and dietarysupplements. Extensive knowledge of compliance requirements and state licensingregulations. Proven leadership and management experience, with a strong focus onteam collaboration in complex environments. Results-driven, with a commitment to opencommunication and adaptability to change. Skilled in managing budgets, costs, andexperienced in leading and supervising complex teams.
Requirements and Personal SkillsEducation and Experience (years / area) : 15-20 years of direct, industry -relatedRegulatory experience in relevant industries with at least 5 years in an ExecutiveRegulatory roleLanguages : EnglishSpecific Knowledge : Pharmaceutical industry experience, FDA rules and regulationknowledge, NDA, BLA and post-approval submission knowledge and experience, strongcGMP and CMC experience. Labeling, advertising, and promotional materialsTravel : 10-15%Personal skills : Management skills, strong interpersonal and people development skills,strong result orientation, supervisory leadership skills, problem solving
