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Sr. Regulatory Compliance Analyst in Charlotte, NC at blu

Date Posted: 1/18/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Charlotte, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/18/2019

Job Description

Reporting directly to the General Counsel, Senior Regulatory Compliance Analyst will specialize in FDA regulatory filings and submissions within company timelines and in accordance with regulatory guidelines and applicable federal laws. The role requires a strong understanding of how the federal regulatory process works and will collaborate with internal and external stakeholders to achieve continued and effective regulatory filings compliance. They will work directly with the US Legal Team and specifically receive onboarding coaching from the Compliance Manager to provide historical submission data to help assess any possible business implications.

Responsibilities:

With supervision, authors, compiles, reviews and submits high-quality regulatory submissions to the FDA

Supports US Legal Team in coordinating clear, concise and accurate responses to inquiries from FDA resulting from their review of the submissions.

Builds robust and organized filing system of regulatory compliance filings and document retention through collection of facts, data, research and documents to use in the drafting documentation for FDA submissions.

Responsible for successfully tracking and maintaining all federal regulatory spreadsheets and databases. This includes being up-to-date on current product SKU lists.

Supports US Legal and product sustainability through developing necessary regulatory submissions to relevant government authorities (including, without limitation, FDA, or State agencies).

Strengthen ability to effectively and appropriately communicate to peers, clients, and management while developing written and oral presentation skills.

Subject matter expert in FDA regulatory submissions with the ability to quickly learn how to navigate the always changing relevant FDA regulatory submission software

Adheres to general standards to promote a cooperative working environment by utilizing communication skills, interpersonal relationships and team building.

 

 

Job Requirements

Bachelor’s Degree or Paralegal at least 3-5+ years of relevant experience. Preferably relevant experience in FDA regulatory filings.

Knowledge and understanding of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Controls Act.

Must be organized, reliable and resourceful professional with practical experience and understanding of the regulatory submission process.

Consumer packaged goods background with demonstrated ability to assume higher levels of responsibility is highly preferred.

Strong analytic skills essential.