Banner Default Image

Vice President of Regulatory Affairs and Quality Assurance

Back to job search

Vice President of Regulatory Affairs and Quality Assurance

  • Location:

    Edison, New Jersey

  • Sector:

    Pharmaceutical

  • Job type:

    Full Time Direct Hire

  • Contact email:

    Jasleen Kaur

  • Job ref:

    7647

  • Published:

    6 days ago

  • Expiry date:

    27 Sep 00:00

Vice President of Regulatory Affairs and Quality Assurance

Edison, NJ
Job ID:7647

  • PhD preferred
  •  cGMP compliance
  • Regulatory Affairs and Quality Assurance experience in the Pharmaceutical Manufacturing Industry
  • Submissions (e-filings)

  •  

Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance and paid PTO.Does this position match your future career goals? Then this opportunity could be the right fit for you.

 

Why should you apply?

  • Excellent work environment with growth opportunities
  • Competitive Salary
  • Top Benefits
 

RESPONSIBILITIES

  • Lead regulatory aspects clinical trials, including maintaining paperwork for grants and funded projects
  • Prepare, submit, and disseminate period reports internally and to regulatory bodies
  • Represent the organization at regulatory and compliance meetings, becoming an expert in compliance matters
  • Direct submission of information to federal bodies, including the FDA
  • Review, analyze, and bring up to compliance all behaviors and paperwork regarding new and existing products and projects
  • Review regulatory publications and communicate information regarding regulatory actions
  • Promote the development of a global regulatory strategy for products registration
  • Provide regulatory counsel to different groups within company
  • Formulate and apply department budgets and organizational structures
  • Review packaging and labeling as well as promotional and sales training content

 

QUALIFICATIONS

  • Minimum Bachelor’s Degree
  • 10+ years of experience with regulatory planning
  • PhD preferred
  •  cGMP compliance 
  • Regulatory Affairs and Quality Assurance experience in the Pharmaceutical Manufacturing Industry
  • Submissions (e-filings)
  • Must understand FDA and international regulatory requirements and have proven ability in preparing and submitting documents to FDA
  • Experience in leading supplier quality functions
  • Must have experience working with FDA

Jasleen Kaur

jasleen@ajuliaexecutivesearch.com

Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.

#ZR