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Regulatory Manager / Senior Regulatory Manager

2 hours, 31 minutes ago
Slovakia
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 32

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review regulatory submissions and communications, including CTA/INDs, annual reports, amendments, scientific advice, orphan designations, paediatric planning, and marketing applications.
  • Develop and review documents for submission to Regulatory Authorities and Ethics Committees to ensure compliance with regulatory standards.
  • Serve as the Global Regulatory Affairs representative in internal and external project team meetings and business development meetings.
  • Work within project teams and, when needed, lead regional or global regulatory projects.
  • Oversee and coordinate Regulatory Affairs Specialists to support submission targets for contracted programs.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Support development and coaching of Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities and help establish company standards for submission quality.
  • Support corporate quality initiatives across clinical solutions business units.
  • Stay current on laws, regulations, and guidelines governing drug development and approval.
  • 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; 7 years required for Senior Regulatory Manager level.
  • Regulatory affairs experience working for a Clinical Research Organisation (CRO).
  • Experience leading clinical submissions.
  • In-depth knowledge of the drug development process, including regulatory milestones.
  • Specialized knowledge of regulatory activities in at least one major region (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 positions and strategy.
  • Working knowledge of clinical trial methodology, protocols, and indications being studied.
  • Knowledge of relevant regulations and guidance supporting pharmaceutical development.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Graduate or postgraduate education preferred.
  • Basic understanding of financial management preferred.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Remote work designation (#LI-Remote).
  • Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
  • Employee input is valued and ideas are encouraged and nurtured.
  • 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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