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Regulatory Operations Manager

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Regulatory Operations Manager

  • Location:

    Cincinnati, Ohio

  • Sector:

    Manufacturing

  • Job type:

    Direct Hire

  • Contact email:

    Jayme Faulkner

  • Job ref:

    12185

  • Published:

    12 days ago

  • Expiry date:

    2021-09-05

Regulatory Operations Manager

Cincinnati, OH

Job Id: 12185

 

Are you looking to make a career change to work in an innovative work environment? This opportunity offers a competitive salary plus an excellent benefits package including medical, dental and much more. Does this position match your future career goals? Then this opportunity could be the right fit for you.

 

RESPONSIBILITIES:

  • Lead global publishing and submission process for domestic and international regulatory bodies
  • Lead the process from inception to approval
  • Use systems and tools for electronic document capture, generation, manipulation, scanning and QC
  • Supervise compliant archiving of all regulatory documents with permissions in place for access
  • Generate and/or supervise the preparation of high-quality regulatory submissions for multiple programs/products in development (e.g. IND, NDA, BLA) with a focus on eCTD
  • Oversee the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards
  • Supervise projects with vendors and contractors to meet schedules and ensure quality
  • Lead Regulatory Operations and collaborate with Regulatory Affairs, Medical Writing, and the cross-functional project team to develop and implement submission strategies and timelines
  • Provide functional and technical guidance regarding submissions of clinical trial applications and marketing applications
  • Maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence, and commitments.
  • Development of training and utilization of regulatory templates, processes, and tools critical to compiling electronic submissions (i.e., software, authoring templates and publishing tools)

 

QUALIFICATIONS:

  • Advanced degree in a related field
  • 5 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology or Pharmaceutical industries
  • Leadership and program management experience
  • Strong ability to manage, lead and innovate thinking
  • Proficient computer, project management attention to detail skills required
  • Excellent communication skills (both written and oral)
  • Desire to grow a strong and productive global regulatory operations organization

 

BENEFITS:

  • Medical
  • Dental
  • Direct Hire

 

Ask for: Jayme Faulkner

jayme@ajuliaexecutivesearch.com

Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.


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