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Regulatory Affairs Associate

Location
Indianapolis, Indiana
Job Type
Permanent
Posted
1 Oct 2021

The Quality & Regulatory Associate (QRA) will be a key driver in reviewing technical documents for cGMP compliance and will provide support to the Directory of Quality and Regulatory in areas including manufacturing compliance, human research study compliance, and state regulatory compliance matters.

Job Responsibilities Include:

· Maintaining and organizing the documentation library

· Review of documentation for drug product batches

· Review and submission of marketing materials for compliance with the Office of Prescription Drugs Promotion regulations

· Processing of state license renewals

· Preparation for regulatory interactions

· Conducting internal and external compliance audits

· Representing Regulatory Affairs on project teams and providing regulatory guidance

· Clearly and convincingly communicating complex issues

  • Sharing expert knowledge of complex issues
  • Reviewing technical documents for cGMP and regulatory compliance
  • Serving as an expert in technical areas in dealing with contract manufacturing organizations in the US
  • Assisting with and/or preparing high-quality submissions to the Food and Drug Administration (NDA's, Supplements, Amendments, and Annual Reports)
  • Assisting with the Quality System
  • Communicating importance of quality assurance throughout the organization and with vendors
  • Keeping up to date on regulatory requirements including monitoring FDA and other agencies regulations and standards
  • Developing regulatory strategy for difficult issues which could significantly impact project timelines and costs
  • Providing regulatory decisions with regard to acceptability of submission documents and decisions
  • Assisting with the and/or filing of applications in accordance with predetermined timelines
  • Other duties as assigned.

Qualifications/Skills/Requirements:

  • At minimum, a bachelor's degree in a scientific discipline and 5 years of experience in pharmaceutical Regulatory Affairs
  • Experience in preparing and filing IND, NDA's, Supplements, Amendments and Annual Reports to FDA
  • Thorough understanding of the CFR, FDA/ICH guidelines and CGMP's, as they pertain to pharmaceuticals

Competitive Salary and Benefits

Career pathway to director level

Collaborative environment

Compliance focused position

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