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Regulatory Manager / Senior Regulatory Manager

1 month ago
Slovakia
Full-time
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 CTAs, INDs, 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 regulatory projects and coordinate Regulatory Affairs Specialists.
  • Maintain project plans, submission trackers, and regulatory intelligence tools.
  • Support regulatory strategy, timelines, quality initiatives, and company standards for new and ongoing programs.
  • Provide ICH GCP guidance, training, and advice to internal and external clients.
  • Stay current with drug development regulations and contribute to 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 industry environment.
  • Experience leading clinical submissions and preparing regulatory applications.
  • Knowledge of the drug development process and regulatory activities in at least one major region, such as the EU or US.
  • Experience with INDs, CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and preclinical study results for regulatory strategy.
  • Knowledge of clinical trial methodology, protocols, indications, and pharmaceutical development regulations.
  • Strong organization, communication, presentation, teamwork, and financial management skills.
  • Ability to manage multiple priorities independently, meet deadlines, travel domestically and internationally, and communicate fluently in English.

Benefits

  • Remote work opportunity.
  • Employee contributions and ideas are valued and supported.
  • Equal opportunity employer with reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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