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 communications
o Lead, manage, review, and submit documents eCTD submission to the FDA 
o Lead the management of all regulatory-related documents and maintain in 
compliance
o Maintain all regulatory files information in compliance with regulatory authority 
requirements
o Renew NDA and devices registrations and update listings with the FDA
o 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 Compliance
o 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 FDA
o Labeling-related change control to finalize labeling update documents
o Develop, manage, review, and approve all promotional materials for all 
marketed products
o Maintain traceability of all promotional material to comply with the regulatory 
requirements

o Design labels to meet FDA requirements of the labeling and prepare labeling 
claim information for the product based on the performed study and FDA 
guidance
o 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 FDA
Competencies/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