Senior Regulatory Affairs Manager

hace 3 semanas

Ourense, Orense, España Worldwide Clinical Trials A tiempo completo

Job Summary

We are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Worldwide Clinical Trials. As a key member of our regulatory affairs department, you will be responsible for reviewing study budgets and costing, participating in business development activities, and preparing regulatory sections of proposals and feasibility reports.

Key Responsibilities

  • Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America regions
  • Provide expert regulatory advice and contribute to regulatory project work
  • Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff
  • Contribute towards the preparation of technical documentation such as IMPDs and IBs
  • Review and make recommendations on all relevant documentation to ensure compliance with ICH GCP and country-specific requirements
  • Provide training, coaching, and mentoring to junior members of staff

Requirements

  • Minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science
  • Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years' experience within clinical research
  • Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
  • Proficient in cross-cultural communication and proficient in both spoken and written English

About Us

Worldwide Clinical Trials is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases enables us to develop flexible plans and solve problems quickly for our customers.

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