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Regulatory Manager / Senior Regulatory Manager

5 hours, 25 minutes ago
Spain
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 132

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review regulatory submissions such as CTA/INDs, annual reports, routine amendments, scientific advice requests, orphan designations, pediatric plans, 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 and business development meetings with internal and external stakeholders.
  • Lead regional or global project work as needed and coordinate Regulatory Affairs Specialists to meet submission targets.
  • Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
  • Support development of Regulatory Affairs Specialists and other operational staff.
  • Contribute to regulatory strategy and timeline development for new study opportunities.
  • Help establish company standards and maintain corporate quality initiatives across clinical solutions business units.
  • Provide ICH GCP guidance, advice, and training to internal and external clients.
  • Stay current on laws, regulations, and guidelines governing drug development and approval.

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.
  • Experience working in regulatory affairs for a Clinical Research Organisation.
  • Experience leading clinical submissions.
  • Strong 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 inform regulatory strategy.
  • Working knowledge of clinical trial methodology, protocols, and indications being studied.
  • Computer literacy, including MS Office / Office 365.
  • Fluent 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 on groundbreaking cancer therapies in oncology and rare disease.
  • Employee contributions are appreciated and ideas are valued and nurtured.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.
  • Formal interview-based hiring process and anti-fraud protections for candidates.

Interested in this position?

Apply directly on the company website

Apply Now

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