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Regulatory Manager / Senior Regulatory Manager

2 hours, 23 minutes ago
Slovakia
Full-time
Senior
Compliance Manager
Operations
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 153

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice requests, orphan designations, paediatric plans, and marketing applications.
  • Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards.
  • Represent Global Regulatory Affairs in project team meetings with internal and external stakeholders.
  • Lead project work regionally or globally when needed.
  • Oversee and coordinate Regulatory Affairs Specialists to meet submission targets for contracted programs.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Support the development of Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.

Requirements

  • Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5 years of regulatory experience required for Manager level and 7 years for Senior Manager level.
  • Experience in regulatory affairs within a Clinical Research Organisation (CRO).
  • Experience leading clinical submissions.
  • In-depth knowledge of the drug development process, including regulatory milestones and at least one major region such as the EU or US.
  • Experience with submissions to Regulatory Authorities, including INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and pre-clinical study results for regulatory strategy and positioning.
  • Working knowledge of clinical trial methodology, protocols, and studied indications.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Graduate or postgraduate qualification preferred.
  • Basic understanding of financial management preferred.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Remote work arrangement indicated by the role listing.
  • Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
  • Chance to contribute ideas and have input valued within a growing organization.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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