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Regulatory Manager / Senior Regulatory Manager

1 month ago
Hungary
Senior
Compliance Manager
Project and Program Management
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 31

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions including INDs, CTAs, amendments, annual reports, scientific advice requests, orphan designations, paediatric plans, and marketing applications.
  • Develop and review documents for Regulatory Authorities and Ethics Committees to ensure compliance.
  • Represent Global Regulatory Affairs in internal, client, project, and business development meetings.
  • Lead regional or global projects and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, regulatory intelligence tools, and leadership updates.
  • Support regulatory strategy and timeline development for new study opportunities.
  • Provide ICH GCP guidance, training, and advice to internal and external clients.
  • Contribute to quality initiatives, company standards, staff development, and continuous process improvement.

Requirements

  • Bachelor’s degree or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5 years of regulatory experience for Manager level or 7 years for Senior Manager level.
  • Regulatory affairs experience in a CRO or pharmaceutical company, including leadership of clinical submissions.
  • Knowledge of the drug development process and regulatory milestones.
  • Specialized regulatory experience in at least one major region, including the EU or US.
  • Experience with INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and preclinical results for regulatory strategy.
  • Working knowledge of clinical trial methodology, protocols, and study indications.
  • Knowledge of pharmaceutical development regulations and guidance.
  • Strong communication, presentation, organizational, project management, teamwork, and problem-solving skills; willingness to travel domestically and internationally.

Benefits

  • Remote work opportunity.
  • Opportunity to contribute to oncology and rare disease therapies.
  • Employee ideas and contributions are valued and supported.
  • Equal opportunity employer with reasonable accommodation available.

Interested in this position?

Apply directly on the company website

Apply Now

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