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 

• Business Development: o Provide regulatory due diligence evaluation of products under consideration for acquisition

• Audits & Inspections: o Support the audits o Host regulatory authority inspections by NJ Department of Health and US FDACompetencies/Career level• Demonstrated ability to multitask across technical, regulatory, and quality assurance functions. Expertise in regulatory operations, including CMC labeling, promotional materials, FDA regulations for NDA’s, medical devices, and dietary supplements. Extensive knowledge of compliance requirements and state licensing regulations. Proven leadership and management experience, with a strong focus on team collaboration in complex environments. Results-driven, with a commitment to open communication and adaptability to change. Skilled in managing budgets, costs, and experienced in leading and supervising complex teams. 

Requirements and Personal Skills• Education and Experience (years/area): 15-20 years of direct, industry -related Regulatory experience in relevant industries with at least 5 years in an Executive Regulatory role• Languages: English• Specific Knowledge: Pharmaceutical industry experience, FDA rules and regulation knowledge, NDA, BLA and post-approval submission knowledge and experience, strong cGMP and CMC experience. Labeling, advertising, and promotional materials• Travel: 10-15%• Personal skills: Management skills, strong interpersonal and people development skills, strong result orientation, supervisory leadership skills, problem solving