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Regulatory Manager / Senior Regulatory Manager

1 hour, 32 minutes ago
Serbia
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 44

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 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, keeping leadership informed.
  • Support regulatory strategy and timeline development for new opportunities and help establish submission-quality standards.
  • Contribute to corporate quality initiatives and provide ICH GCP guidance, advice, and training.
  • Support the development of Regulatory Affairs Specialists and other operational staff.
  • Monitor evolving drug-development laws, regulations, and guidelines.

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 within a CRO or pharmaceutical industry environment.
  • Experience leading clinical submissions.
  • Knowledge of the drug-development process, regulatory milestones, 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, study indications, and pharmaceutical-development regulations.
  • Availability for domestic and international travel, including overnight stays.
  • Strong communication, presentation, organization, problem-solving, financial-management, and teamwork skills; fluency in written and spoken English.

Benefits

  • Remote work opportunity.
  • Employees are encouraged to contribute ideas and influence positive organizational change.
  • 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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