Regulatory Manager / Senior Regulatory Manager

5 hours, 34 minutes ago
Full-time
Senior
Project and Program Management
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

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, paediatric plans, and marketing applications.
  • Develop and review documents for Regulatory Authorities and Ethics Committees.
  • Represent Global Regulatory Affairs in internal, client, project-team, and business-development meetings.
  • Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools while updating leadership.
  • Support staff development, quality initiatives, regulatory standards, and timeline planning.
  • Provide ICH GCP guidance, training, and advice to internal and external clients.
  • Monitor applicable laws, regulations, and guidelines and promote continuous process improvement.

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 in a CRO or pharmaceutical company, including leadership of clinical submissions.
  • Knowledge of the drug development process 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.
  • Working knowledge of clinical-trial methodology, protocols, and studied indications.
  • Knowledge of pharmaceutical development regulations and guidance.
  • Strong communication, presentation, organizational, problem-solving, and record-keeping skills.
  • Availability for domestic and international travel, including overnight stays.

Benefits

  • Remote work opportunity.
  • A role supporting development of groundbreaking cancer therapies.
  • Opportunities to contribute ideas and influence positive organizational change.
  • Equal opportunity employer with reasonable accommodation support.

Interested in this position?

Apply directly on the company website

Apply Now

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