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Regulatory Manager / Senior Regulatory Manager

1 month ago
United Kingdom
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 31

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.
  • Represent Global Regulatory Affairs in project, client, and business development meetings.
  • Lead regional or global regulatory projects and coordinate Regulatory Affairs Specialists.
  • Maintain project plans, trackers, and regulatory intelligence tools.
  • Support staff development, training, quality initiatives, and company regulatory standards.
  • Provide ICH GCP guidance and training to internal and external clients.
  • Monitor regulatory laws, regulations, and guidelines and contribute to strategy and timeline development.

Requirements

  • Bachelor’s degree or equivalent experience, preferably 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.
  • Experience leading clinical submissions in at least one major region, such as the EU or US.
  • Knowledge of drug development processes, regulatory milestones, INDs/CTAs, amendments, scientific advice procedures, and post-approval submissions.
  • Ability to interpret clinical and preclinical results for regulatory strategy.
  • Knowledge of clinical trial methodology, protocols, indications, and pharmaceutical development regulations.
  • Availability for domestic and international travel, including overnight stays.
  • Strong project management, organizational, communication, presentation, and record-keeping skills.
  • Ability to manage multiple priorities independently, resolve problems, motivate teams, and support continuous improvement.

Benefits

  • Remote work opportunity.
  • Opportunity to contribute to oncology and rare-disease clinical research.
  • Employee ideas and contributions are valued and supported.
  • 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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