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Associate Director of Regulatory Affairs

Exeltis
Florham Park, NJ
  • Posted: over a month ago
  • Other
Job Description
Salary:

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.

Exeltis

Address

Florham Park, NJ
07932 USA

Industry

Government

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