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Regulatory Operations Manager in Cincinnati, OH

Medpace

Cincinnati, OH 45202
6w ago
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compensation:

$100K - $150K*

specialty:

Operations Management

experience:

5 - 7 years

Job Description

Job Summary

Experienced Regulatory Operations professional with experience in complete pharmaceutical development life cycle management. Expert in global eCTD publishing for all project initiation through marketing application submissions, including post-approval. Strong leadership, clear vision, able to motivate and create nimble high performing teams. Experienced manager of Regulatory Operations staff and processes with a focus on delivery with excellence while maintaining quality and compliance.

Responsibilities

  • Oversee global publishing and submission process for domestic and international regulatory bodies
  • Manage the process from inception to approval
  • Utilize systems and tools for electronic document capture, generation, manipulation, scanning and QC
  • Oversee compliant archiving of all regulatory documents with permissions in place for access
  • Prepare and/or oversee the preparation of high-quality regulatory submissions f
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Valid through: 2020-3-4

About Medpace

Medpace (alt. MedPace) is a midsize, clinical contract research organization (CRO) based in Cincinnati, Ohio. Medpace provides services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. In February 2014, Medpace was sold to private equity firm Cinven by CCMP Capital for around $900 million.
Total Jobs:
23
Total Experts:
3
Average Pay:
$108,783
Total value of jobs:
$4,025,000
% Masters:
46%
* Ladders Estimates