Senior Director, Regulatory Affairs - Advertising & Promotion
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
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 withartwork 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 labelingclaim 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 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 NDAs, 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 SkillsEducation and Experience (years/area): 15-20 years of direct, industry -related
Regulatory experience in relevant industries with at least 5 years in an ExecutiveRegulatory role
Languages: English
Specific Knowledge: Pharmaceutical industry experience, FDA rules and regulation
knowledge, NDA, BLA and post-approval submission knowledge and experience, strongcGMP 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