Regulatory Data Management Director

2 weken geleden

Nederland Planet Pharma Voltijd

Regulatory Data Management Director – Life Sciences (Remote/Hybrid)

Are you an experienced leader in Regulatory Data Management with a passion for driving compliance, quality, and efficiency in the pharmaceutical, biotech, or medical device industry ? We are seeking a Regulatory Data Management Director to lead a high-performing team in regulatory information management, data quality, and electronic submissions .

This role offers an exciting opportunity to shape regulatory data processes, implement cutting-edge Regulatory Information Management Systems (RIMS) , and collaborate with industry leaders.

Key Responsibilities

  • Lead and mentor a team of regulatory data specialists, ensuring high-quality project and service delivery.
  • Oversee regulatory data management processes , ensuring compliance with global regulatory requirements.
  • Implement and optimize Regulatory Information Management Systems (RIMS) such as Veeva Vault RIM, EXTEDO EXTEDOpulse, Ennov RIM, Lorenz docuBridge, and others.
  • Drive data quality initiatives , including data migration, cleansing, and remediation .
  • Provide strategic input on vendor selection, system implementation, and process development .
  • Collaborate with Regulatory Affairs teams to ensure seamless regulatory submissions and reporting.
  • Stay updated on global regulatory changes, ensuring compliance with evolving industry standards.

What We’re Looking For

  • 10+ years of experience in Regulatory Data Management, Regulatory Affairs, or Regulatory Operations .
  • Expertise in regulatory information management, electronic submissions (eCTD, IDMP, xEVMPD), and compliance .
  • Experience working with RIMS, data governance, and process optimization .
  • Strong leadership and project management skills , with the ability to coach and develop teams.
  • Knowledge of data quality frameworks, system integrations, and regulatory technology solutions.
  • Excellent communication and stakeholder management skills.

Why Join Us?

  • Work in a dynamic and fast-growing organization that supports global regulatory operations.
  • Opportunity to lead high-impact projects and drive regulatory technology advancements.
  • Collaborate with top industry professionals in regulatory data management and compliance.
  • Flexible remote or hybrid work options depending on location.

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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