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Regulatory Manager / Senior Regulatory Manager

1 hour, 40 minutes ago
United Kingdom
Full-time
Senior
Operations Manager
Operations
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 132

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 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 activities for a region 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 informed.
  • Assist in developing Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities.
  • Support corporate quality initiatives and uphold standards for submitted information.
  • Stay current on laws, regulations, and guidelines governing drug development and approval.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.
  • Represent Global Regulatory Affairs in business development meetings.

Requirements

  • Bachelor’s degree, or equivalent experience, ideally in a scientific or healthcare discipline.
  • 5 years of regulatory experience required for Manager level or 7 years for Senior Manager level.
  • Computer literacy with MS Office / Office 365.
  • Fluent in English.
  • Regulatory affairs experience working for a Clinical Research Organisation.
  • 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), including INDs/CTAs, amendments, Scientific Advice procedures, and post-approval submissions.
  • Ability to understand clinical and pre-clinical study results and interpret them for regulatory strategy.
  • Working knowledge of clinical trials methodology, protocols, and indications being studied.
  • Knowledge of relevant regulations and guidance supporting pharmaceutical development.
  • Availability for domestic and international travel, including overnight stays.
  • Graduate or postgraduate degree preferred.
  • Basic understanding of financial management preferred.

Benefits

  • Remote work designation (#LI-Remote).
  • Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
  • Chance to contribute ideas and have input valued and nurtured.
  • Inclusive employer committed to equal opportunity in hiring.
  • Reasonable accommodation support for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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