Regulatory Manager

hace 2 semanas

Madrid, Madrid, España Jobgether A tiempo completo
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Manager (Remote). In this role, you will play a crucial part in guiding regulatory strategy and development throughout the clinical trials process. Your expertise will ensure the optimal conduct of trials, compliance with regulations, and the timely submission of well-organized regulatory documents. This position offers you the chance to impact the clinical development life cycle significantly and to make a difference in bringing life-changing therapies to patients. Accountabilities
  • Provides regulatory guidance throughout the clinical development life cycle
  • Compile, coordinate and review applications to Regulatory Authorities including CTA/IND and marketing applications
  • Develops and/or reviews documents intended for submission to Regulatory Authorities and/or Ethics Committees
  • Serve as representative of Global Regulatory Affairs at project team meetings
  • Works within a project team, leading projects where necessary
  • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
  • Maintain project plans, trackers and regulatory intelligence tools
  • Assist in the development of Regulatory Affairs Specialists and operational staff
  • Provide input into regulatory strategy and timeline development for new opportunities
  • Participate in maintaining corporate quality initiatives across clinical solutions
  • Stay updated on laws, regulations and guidelines governing drug development
  • Provide guidance on ICH GCP to internal and external clients
Requirements
  • Bachelors degree in a scientific or healthcare discipline, or equivalent experience
  • 5 years Regulatory experience required for the Manager level; 7 years for Senior Manager level
  • Proficient in MS Office/ Office 365
  • Fluent in English
  • Possesses a basic understanding of financial management is preferred
Benefits
  • Discretionary annual bonus
  • Private medical insurance
  • MultiSport Card
  • Life insurance
  • Pension plan
  • Home working allowance
  • Vacation days
Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team We appreciate your interest and wish you the best Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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