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Job Order:

6077

Staff Representative:

Tim Jadwin

Position:

Manager Of Regulatory Affairs

Location:

Illinois

Company Summary:

A leading supplier of specialty and generic liquid pharmaceutical products.

Description:


Responsibilities:
Responsible for all activities of the Regulatory Affairs Department. Main objectives are to file and obtain ANDA approvals and to ensure compliance with FDA regulations.

Typical Duties:
  • Submits quality submissions of ANDAs, AADAs, Supplements and Amendments in a timely manner.
  • Reviews and submits Annual Reports, Periodic Reports, Annual Drug Reviews, Adverse Drug Experiences and Recall Coordination Activities.
  • Contact person with Project Managers at FDA-CDER.
  • Participates in product review meetings, evaluates project priorities and coordinates activities to facilitate timely procurement, compilation, review and submission of ANDA’s and Supplements; Monitors review and approvals.
  • Interfaces with QC/QA, R&D, Marketing and Manufacturing in data generation and strategy development.
  • Provides regulatory/technical input for product development and reformulation.
  • Interprets regulations and provides consultancy for compliance needs.
  • Provides answers to Marketing inquiries.
  • Supervises staff and assists in their professional development, performance evaluation and salary administration.
  • Prepare and review documents for INDs, NDAs, and DMFs
  • Review and submit protocol changes and safety reports for clinical studies
  • Coordinate and process documents for registration
  • Review drug advertisements / promotions
  • Write and revise SOP’s related to labeling, recalls, and other issues
  • Manage change control system for drug products
  • Manage submission of annual reports, drug listings, and supplements
  • Generate and coordinate documents for ANDA submissions
  • Organize doocuments for pre-approval inspection
  • Review and submit materials to the FDA
  • Strategy with the FDA
  • Strategy with the Department and other departments
  • Respond to deficiencies
  • Negotiate with FDA on all issues
Job Specifications:
  • Advanced degree in a scientific/technical discipline
  • Five to seven years of pharmaceutical industry experience and a minimum of three to five years FDA submission experience.


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