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Regulatory Manager / Senior Regulatory Manager

1 hour, 45 minutes 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 146

Description

  • Provide regulatory strategy and development guidance across the clinical development lifecycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice packages, 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.
  • Represent Global Regulatory Affairs in project team meetings with internal and external stakeholders.
  • Lead regional or global projects when needed and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Support the development of Regulatory Affairs Specialists and other operational staff.
  • Provide input on regulatory strategy and timeline development for new study opportunities.
  • Help establish company standards and support corporate quality initiatives across clinical solutions business units.
  • Stay current on laws, regulations, and guidelines governing drug development and approval, and provide ICH GCP guidance and training to clients.

Requirements

  • Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5 years of regulatory experience required for the Manager level.
  • 7 years of regulatory experience required for the Senior Regulatory Manager level.
  • Experience working in regulatory affairs 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, 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 to support regulatory positions and strategy.
  • Working knowledge of clinical trial methodology, protocols, and indications under study.
  • Knowledge of relevant regulations and guidance supporting pharmaceutical development.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Availability for domestic and international travel, including overnight stays.
  • Graduate or postgraduate education preferred.
  • Basic understanding of financial management preferred.

Benefits

  • Remote work designation indicated by #LI-Remote.
  • Opportunity to work on oncology and rare disease programs.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Access to the company’s privacy and applicant privacy notices.

Interested in this position?

Apply directly on the company website

Apply Now

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