Digital Lead For Medical, Regulatory Affairs & Pharmacovigilance Platforms

Opella

Barcelona, Spain
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Medical, regulatory affairs & pharmacovigilance experience
21 cfr part 11 regulatory compliance knowledge
Vendor management and contract negotiation skills
** Opella is seeking a Digital Lead for its Medical, Regulatory Affairs, and Pharmacovigilance Platforms in Barcelona, Spain. The ideal candidate will have extensive experience in digital leadership within the life sciences or consumer healthcare industry, focusing on implementing and optimizing digital solutions to enhance regulatory compliance and data management. **

Job Summary

  • The role serves as a strategic partner dedicated to revolutionizing healthcare by enhancing information systems for Medical, Regulatory, and Pharmacovigilance operations.
  • Candidates must lead the implementation of digital solutions ensuring strict adherence to regulatory frameworks like 21 CFR Part 11 and FDA standards.
  • This position requires building and mentoring a high-performing team while managing relationships with technology vendors to optimize global health outcomes.

Matching Summary

Match Score: 75

** Opella is seeking a Digital Lead for its Medical, Regulatory Affairs, and Pharmacovigilance Platforms in Barcelona, Spain. The ideal candidate will have extensive experience in digital leadership within the life sciences or consumer healthcare industry, focusing on implementing and optimizing digital solutions to enhance regulatory compliance and data management. **

Skills & Requirements

Must-have

  • Medical, Regulatory Affairs & Pharmacovigilance experience
  • 21 CFR Part 11 regulatory compliance knowledge
  • Vendor management and contract negotiation skills
  • Experience with ARIS G or similar PV platforms
  • Team leadership and strategic planning capabilities

Nice-to-have

  • Entrepreneur mindset and adaptability to change
  • Strong written and oral communication skills
  • Fluency in Spanish or French languages
  • Experience with Veeva RIMS and LifeSphere MultiVigilance
  • Consumer-centric transformation focus

Key Requirements

  • Bachelor's degree required; Master's preferred
  • Extensive experience in Lifesciences digital leadership roles
  • Proven track record in managing Medical RA & PV technology implementations

Work Rights

Not specified

Tailored Resume

Cover Letter