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Regulatory Manager / Senior Regulatory Manager

2 hours, 44 minutes ago
Romania
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 63

Description

  • Provide regulatory guidance throughout the clinical development life cycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, routine amendments, scientific advice meetings, orphan designations, paediatric planning, and marketing applications.
  • Develop and review documents intended 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 updated.
  • 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 for the Manager level or 7 years for the Senior Manager level.
  • Regulatory affairs experience working for a Clinical Research Organisation.
  • Experience leading clinical submissions.
  • In-depth knowledge of drug development, regulatory milestones, and 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 understand clinical and pre-clinical study results to support regulatory positions and strategy.
  • Working knowledge of clinical trials methodology, protocols, and indications being studied.
  • Computer literacy with MS Office/Office 365.
  • Fluency 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 in a company focused on groundbreaking cancer therapies.
  • Employee ideas are valued and supported, with input encouraged across the 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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