Senior Regulatory Affairs Associate

Responsibilities/Overview

HLM Clinicals is currently seeking a Senior Regulatory Affairs Associate for a client in Cranbury, NJ
We are currently seeking a Senior Regulatory Affairs Specialist. This person would: ensure marketing approval of drug products in the US; be a regulatory liaison for new product development and changes to existing products; perform job tasks independently and supervise regulatory staff; and provide strategic input and guidance to cross-functional project teams. This position will - Plan and prepare ANDA, amendments and post approval submissions such as supplements and annual reports. Provide input for regulatory requirements and project schedules in interdepartmental meetings.

Job Description & Responsibilities
Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.
Independently manage preparation (in paper or electronic formats (eCTD)), submission and monitoring progress of FDA review of ANDA's
Communication with functional groups for coordination and preparation of data for submission to FDA
Manage all Regulatory, Federal and State License requirements
Review change controls for regulatory requirements and according to appropriate regulations and guidance’s.
Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc)
Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.
Review labels as per FDA guidance
Regulatory support in drug listing.
Perform other duties as assigned

Job Qualification Requirements
BS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy is mandatory
2 years experience in pharmaceutical regulatory affairs (mandatory)
Attention to detail
Excellent oral and written communication skills
Knowledge of US drug regulatory requirements (mandatory)
PREFERRED
Experience in eCTD preferred





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HLM Recruiter

resume@hlmclinicals.com