Director, Regulatory Data Office Leader

Scorpion Therapeutics; Horsham (PA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Lead for the global Regulatory Data Office to drive data governance, stewardship, and quality for regulatory affairs data across the enterprise.

The role emphasizes governance, data standards alignment with global regulatory requirements (IDMP, xEVMPD), and leadership of a team of data stewards in a hybrid work setup across multiple sites in the US.

Qualifications

• Minimum 10 years in pharma/healthcare, with at least 2 years in data governance roles.
• Bachelor's in Science, Business, or related.
• Advanced degrees preferred.

Responsibilities

• Oversee regulatory data integrity.
• Establish governance policies.
• Chair the Regulatory Data Council.
• Ensure data standards align with global regulatory requirements (e.g., IDMP, xEVMPD).
• Manage day-to-day operations of the Regulatory Data Hub.
• Support RIM transformation initiatives.
• Collaborate across R&D, IT, and Data Science to embed trusted data into strategic platforms like URP and AI tooling.
• Lead and develop a team of data stewards, fostering high performance and cross-functional alignment.

Skills

data analysis

governance

regulatory systems

project leadership

Education

Bachelor's in Science, Business, or related

Advanced degrees preferred

Tools

Veeva Vault RIM

Job description

Role

Lead the global Regulatory Data Office within Johnson & Johnson's Innovative Medicine R&D, focusing on data governance, stewardship, and quality for regulatory affairs data.

Responsibilities

• oversee regulatory data integrity
• establish governance policies
• chair the Regulatory Data Council
• ensure data standards align with global regulatory requirements (e.g., IDMP, xEVMPD)
• manage day-to-day operations of the Regulatory Data Hub
• support RIM transformation initiatives
• collaborate across R&D, IT, and Data Science to embed trusted data into strategic platforms like URP and AI tooling
• lead and develop a team of data stewards, fostering high performance and cross-functional alignment

Qualifications

• minimum 10 years in pharma/healthcare, with at least 2 years in data governance roles
• Bachelor's in Science, Business, or related
• advanced degrees preferred

Skills

• data analysis
• governance
• regulatory systems (e.g., Veeva Vault RIM)
• project leadership

High-Value

• focus on regulated pharmaceutical data
• digital transformation
• AI integration
• global health authority compliance
• cross-functional collaboration

Work Setup

hybrid in Horsham PA, Raritan NJ, or Titusville NJ.