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Regulatory Manager / Senior Regulatory Manager

6 hours, 11 minutes ago
Spain
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 175

Description

  • Provide regulatory guidance throughout the clinical development lifecycle.
  • Compile, coordinate, and review submissions to Regulatory Authorities, including CTA/INDs, annual reports, amendments, scientific advice requests, orphan designations, paediatric planning, and marketing applications.
  • Develop and review documents for 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.
  • 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.
  • Support the development of Regulatory Affairs Specialists and other operational staff.
  • Provide input into regulatory strategy and timeline development for new study opportunities.
  • Support corporate quality initiatives and promote high-quality 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 for the Manager level or 7 years for the Senior 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 for regulatory strategy and positioning.
  • Working knowledge of clinical trial methodology, protocols, and indications being studied.
  • Knowledge of relevant regulations and guidance supporting pharmaceutical development.
  • Computer literacy with 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.
  • Strong interpersonal skills and ability to work in a team environment.
  • Ability to manage multiple tasks in a fast-moving environment with good record-keeping skills.
  • Ability to work independently, prioritize workload, and meet deadlines with limited support.
  • Strong communication skills, including formal presentations to colleagues, investigative staff, and clients.

Benefits

  • Remote work indicated by the #LI-Remote posting tag.
  • Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
  • Employee ideas are valued and encouraged, with input into company decisions.
  • Equal Opportunity Employer workplace.
  • Reasonable accommodation available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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