Regulatory Affairs Specialist

2 weeks ago


Denville, New Jersey, United States Ingenus Full time
Job Title:

Regulatory Affairs Specialist

About the Role:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ingenus Pharmaceuticals. The ideal candidate will have 8+ years of experience in regulatory strategy and filing of ANDAs, New Drug Applications (NDA) in a pharmaceutical industry.

This role requires hands-on experience of using any e-CTD build software, ability to multi-task in a fast-paced environment with minimal supervision, and excellent attention to detail and accuracy maintaining consistently high-quality standards.

Responsibilities:
  • Prepare and review various modules of ANDAs, NDAs, and responses to FDA queries.
  • Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for NDA's.
  • In-depth knowledge and experience of regulatory CMC documents review, and approval is required.
  • Provide regulatory guidance to cross-functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms.
Requirements:
  • Bachelor's degree with 8 plus years' experience in regulatory strategy and filing of ANDAs, New Drug Applications (NDA) in a pharmaceutical Industry.
  • Hands on experience of using any e-CTD build software.
  • Ability to work flexibly, organize own workload and effectively manage competing priorities.
What We Offer:

Estimated salary: $95,000 - $110,000 per year. Benefits include competitive benefits package and opportunities for career growth and professional development.



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