Associate Director of Regulatory Affairs

Role Overview

Responsible for marketed products including prenatal vitamins and medical devices.

Primary Duties & Responsibilities

• Responsible for preparing and submitting NDA annual reports, supplements, and other submissions required for marketed drug products in eCTD format.
• Provide regulatory assessment of CMC change controls. For changes requiring the filing of supplemental NDAs, prepare and submit relevant documents and updates to the dossiers for approval.
• As a member of the Promotional Review Committee, ensure the review and approval of branded and unbranded promotional materials are in regulatory compliance with relevant laws and regulations.
• Lead the implementation of labeling changes for drugs, medical devices and dietary supplements including tracking and maintaining NDC/NHRCI numbers and labeling component and versions numbers.
• Ensure regulatory compliance of marketed dietary supplements in terms of   labeled claims and promotional materials.
• Maintain and update establishment registrations and drug listings.
• Maintain and update regulatory SOPs and support the review and implementation of policies and procedures.
• Represent the company in NJ State and FDA site inspections.
• Act as the designated representative for company’s manufacturer and wholesale distributor licenses.

Additional Duties & Responsibilities

• Ensures the on-time submission of all post marketing reports.
• Critically reviews and provides solutions to promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities.
• Develops and prepares CMC-related submission documents and labeling changes ensuring they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle.
• Understands regulatory lifecycle management ensuring NDAs in eCTD format are up to date and accessible to FDA.
• Works independently, proactively, and cross-functionally with internal and external team members.
• Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines.

Competencies/Career Level

Please list all that apply: Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.

Requirements and personal skills

• Education: Bachelor’s degree in Chemistry or equivalent
• Languages: Fluent in Proficiency in Spanish is desirable.
• Experience (years/area): +7 years of experience in regulatory affairs.
• Personal skills: Please list all that apply General management skills, strong interpersonal and people development skills, strong written and oral communication skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.