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Regulatory Manager / Senior Regulatory Manager

5 hours, 49 minutes ago
Serbia
Full-time
Senior
Compliance Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 78

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, pediatric plans, and marketing applications.
  • Develop and review documents for Regulatory Authorities and Ethics Committees to ensure regulatory compliance.
  • Represent Global Regulatory Affairs in internal, client, project-team, and business-development meetings.
  • Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, and regulatory intelligence tools, and report progress to Regulatory Leadership.
  • Support staff development, regulatory training, quality initiatives, and company standards for submission quality.
  • Provide ICH GCP guidance and contribute to regulatory strategy and timelines for new opportunities.

Requirements

  • Bachelor’s degree or equivalent experience, preferably 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 setting.
  • Experience leading clinical submissions and knowledge of the drug development process and regulatory milestones.
  • Specialized regulatory experience in at least one major region, such as the EU or US, including INDs/CTAs, amendments, scientific advice, 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 communication, presentation, organization, record-keeping, problem-solving, and project-management skills.
  • Ability to manage multiple priorities independently, motivate project teams, and work effectively in a collaborative environment.
  • Availability for domestic and international travel, including overnight stays; fluent written and verbal English.

Benefits

  • Remote work opportunity.
  • Opportunity to contribute to oncology and rare-disease drug development.
  • Employee ideas and contributions 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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